Document Number: 423-3

Date of Issue: August 15, 2022

Revision: 3.5

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 TABLE OF CONTENTS

1. INTRODUCTION ………………………………………………………………………... 4
1.1 Indications for Use..………………………………………………………………… 4
2. SYSTEM SETTINGS……………………………………………………………………. 5
2.1 System Requirements …………………………………………………………….. 5
2.2 Network Settings …………………………………………………………………… 5
3. INSTALLATION AND UPDATE ………………………………………………………. 6
3.1 Update ……………………………………………………………………………… 9
4. USER INTERFACE …………………………………………………………………….. 10
4.1 Multi-Planar Reconstruction (MPR) Display ……………………………………. 10
4.1.1 Axial view ………………………………………………………………….…. 10
4.1.2 Coronal view …………………………………………………………………. 10
4.1.3 Sagittal view ………………………………………………………………….. 11
4.2 How to Adjust the Planes ………………………………………………………… 11
4.3 3D Rendering Window (Volume) ………………………………………………… 12
4.4 Panoramic Mode …………………………………………………………………… 13

4.5 Rotating Slice Window …………………………………………………………… 16

4.6 Buttons and Basic Functions …………………………………………………….. 16
4.6.1 INFO Panel …………………………………………………………………… 17
4.6.2 Tool Panel ……………………………………………………………………. 17
4.6.3 Settings Menu ……………………………………………………………….. 18
4.6.4 Visualization Tools …………………………………………………………... 21
4.6.5 Tab Panel …………………………………………………………………….. 21
5. INPUT DATA (DICOM) ………………………………………………………………… 22
5.1 DICOM "Cutting"………………………………………………………………….… 23
5.2 DICOM to STL Conversion ……………….……………………………….…….. 24
5.3 DICOM Segmentation …………………………………………………………….. 25
5.3.1 Options ……………………………………………………………………………. 27
6. INPUT DATA (STL) …………………………………………………………………… 29
7. NERVE CANAL TRACING …………………………………………………………… 36

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8. VIRTUAL CROWNS PLACEMENT ………………………………………………….. 37
9. IMPLANT PLANNING …………………………………………………………………. 39
10. ANCHOR PIN PLANNING …………………………………………………………… 48
11. SURGICAL GUIDE CREATION …………………………………………………….. 52
11.1 Surgical Guide Based on Prosthesis ……….………………………………….. 57
12. SURGICAL PROTOCOL ……………………………………………………………... 58
WARNINGS AND PRECAUTIONS ……………………………………………………… 59
ANNEX A – How to evaluate the quality and accuracy of alignment................... 61
ANNEX B – Dual Scan Technique ……………………………………………………… 62
ANNEX C – How to anonymize your project file ……………………………………. 66
ANNEX D – Cloud Service ………………………………………………………………. 67
ANNEX E – Cybersecurity Hygiene …………………………………………………… 71
ANNEX F – Implant Libraries for ImplaStation ……………………………………… 71
REVISIONS ………………………………………………………………………………… 73

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1. INTRODUCTION

ImplaStation is stand-alone software designed for trained qualified dental practitioners.

The key scientific concept of the ImplaStation software is the visualization of a patient’s
medical image data (DICOM file from third-party CT/CBCT scanners) to pre-operative
digital implant planning, surgical guide (drill guide) file (output of the pre-operative
implant planning) creation.
The data acquired by the optical scanner (scanned surface of the maxilla or mandible)
can be aligned to the CT/CBCT reconstruction through a point-based registration
technique.
Virtual crown(s) design and nerve tracing can be used as additional tools to assist the
specialist during an implant planning process.
The ImplaStation library contains implant, abutment, drill, and sleeve files, which are
encrypted files and approved by the corresponding implant manufactures. The software
allows designing the surgical guide (drill guide) file and exporting the generated file to a
3rd party external system for manufacturing.

The followings are the major functions of ImplaStation:

 Patient DICOM dataset loading and visualization*

 Data (DICOM, .stl files) input; Data (.stl file) output for manufacturing; Surgical
report (drilling protocol .pdf) output.
 Nerve tracing
 Virtual crown(s) positioning
 Virtual implant placement
 Collision detection
 Patient treatment plan creation
 Surgical guide design and creation
 Surgical protocol design and creation
 Project information management and sharing
 Designed surgical guide data can be exported to a third-party system for
manufacturing**

*The software is not intended for diagnosis, please use the software offered by the
Computed Tomography Scanner manufacturer, on which scanning was performed for
the diagnosis and expert opinions. The software does not apply any compression,
modifications, or adaptation to the DICOM files and model surface scan STL-files during
their upload, alignment, design, and export.

**Paid option

Note! The software as medical device has no patient contact

1.1 Indications for Use

ImplaStation is stand-alone software designed for trained qualified dental practitioners,

including dentists and dental technicians.
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The software can be used to visualize a patient’s medical image dataset output in
DICOM format from third-party CT/CBCT scanners.
ImplaStation is intended for use as a pre-operative tool for the dental implant(s)
positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s)
and for the surgical guide planning result file creation. The surgical guide can be
manufactured using a planning result file when used as input to 3D manufacturing
systems.
3D manufacturing is out of ImplaStation software control, depends on many external
factors and lie within the sole responsibility of the user.

2. SYSTEM SETTINGS

2.1 System hardware and software requirements

Minimum System Requirements Recommended

Windows 8 Home
Windows 8.1 Home
Windows 10 Home
Windows 7 PRO
OS Windows 8 PRO
Mac OS 10.12 and higher
Windows 8.1 PRO
Windows 10 PRO
Mac OS 10.12 and higher
Central
Intel Core i5
Processing Unit Intel Core i3
Intel Core i7 or equivalent
(CPU)

Memory (RAM) 4GB 8GB or more

Intel HD Graphics 615

NVIDIA GeForce 2GB or
Graphics Card Intel HD Graphics 620
more
NVIDIA GeForce 1GB
100GB of free space or
HDD 3GB of free space
more
Monitor 1920 x 1080 pixels or
1600 x 900 pixels
resolution higher

2.2 Network Settings

In order to identify user account, import/export order forms, share ImplaStation projects
and communicate with customer partner(s), personal computer must be connected to
the Internet.
Internet connection is required for the support, help and training provided by Customer
Support Service.

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3. INSTALLATION AND UPDATE

Open download directory on ImplaStation

website (implastation.com), then click on
the download link. Start installation
process manually by executing the
loaded ImplaStationSetup file on
personal computer.

Choose language settings and click Next

to move to the next step

Click Next to move to the next step

Browse for app location and click Next to

move to the next step

It is recommended to locate main

ImplaStation folder in the "C:" drive root

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Select the additional tasks you would like
setup and click Next to move to the next
step

For not experienced user it is

recommended to choose all options

Click Install to continue with the

installation

Click Finish

Open the software and fill up the

registration form.

It is recommended to choose option

“I want to receive promotions, an
overview of new products and features”.
It is recommended to enter phone
number.

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 Press OK, then software will be
automatically closed. Please check your
e-mail.

If you already have ImplaStation License

Key find file on your computer, then click
OK

Open your inbox e-mail folder, save

attached key-file to a hard drive, open it
by double clicking to complete a
registration process

Optionally - you may specify a path to the

saved key file using the Registration
Form of ImplaStation app, open "I have a
Registration Key File" tab > "Browse" tab,
choose saved Key-file in the folder and
press OK

Key file(s), “Library” folder and other important information are located in the folder
Note!
"ImplaStation" (C:\Users\”user name”\AppData\Roaming\ImplaStation) for Windows

If the ImplaStation License Key file is not received after registration process, check the
SPAM and other folders for incoming messages in your specified email box.
For technical issues, email us at [email protected]
Find the video instructions for how to install and activate the software on ProDigiDent
YouTube channel.
The ImplaStation License Key file is "attached" to the specified email and hardware ID
of the PC from which registration was done.

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The ImplaStation License Key file should not be copied and used with another PC.
There is no option to activate app installed on another (non proper) PC in aim to protect
the account from thefts and to protect the user's personal information.
One email address maybe specified for unlimited quantity of PC (home, work, office etc.)
Only an e-mail owner able to control ImplaStation License Key files transfers.

The ImplaStation Settings menu enables user to register several accounts, attached to
different e-mail addresses. In case of several accounts are registered on one PC the
“Select user” window appears.

If your browser automatically converts key-file to text - copy an appropriate string with
the code to bookmark "I have a registration key-file"

The window shows all available user

accounts. Please select the one you want
and press OK.

3.1 Update

To check the current version of the software click the "Help" button, then select
"About application" line

If an update is available, the "Update Application" menu pops up automatically when

the software starts up. Click "OK" to update (recommended), or click "Cancel" to
continue to work with the current version.

If the update does not occur, or it gives you an error, reinstall the software by clicking
the link in the update dialog window.

Software installation package or update package is a secured deliverable

Warning! package. This secure deliverable package is uniquely encrypted and key-
hashed to ensure the integrity and authenticity of its origin.

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4. USER INTERFACE

The ImplaStation user interface enables users to visualize the patient's DICOM dataset
using the Coronal, Sagittal, Axial, Panoramic, Rotating Slice and 3D view in
corresponding windows.
MPR and Panoramic display can be used to generate interactive slices in free, oblique
planes.

4.1 Multi-Planar Reconstruction (MPR) Display

The software automatically provides multi-planar windows (coronal, sagittal, and axial)
and 3D view. This Multi-Planar Reconstruction (1) can be used to work on any spatial
plane to obtain different types of high-quality diagnostic images obtained from 3 rd parties
medical CT or CBCT scanners.

4.1.1 Axial view

Axial view is a horizontal cut away slice of the maxillo-facial area as seen from the
bottom (2).

By scrolling the mouse wheel or clicking and dragging the slider (3), It is possible to view
the whole sequence of axial images. The name of the axial window and indicator line of
the axial slice are marked in green. The indicator line of the axial slice appears in the
coronal, sagittal, panoramic, and 3D windows.

4.1.2 Coronal view

Coronal View is a vertical cut away slice of the body as seen from the front (4).

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By scrolling the mouse wheel or clicking and dragging the slider (5), it is possible to view
the whole sequence of cross-sectional images. The name of the coronal window and
indicator line of the coronal slice are marked in yellow. The indicator line of the coronal
slice appears in the axial, sagittal, panoramic, and 3D windows.

4.1.3 Sagittal view

Sagittal View is a vertical cut away slice which divides the body into right and left parts
(6).

By scrolling the mouse wheel or clicking and dragging the slider (7), it is possible to view
the whole sequence of sagittal images. The name of the sagittal window and indicator
line of the sagittal slice are marked in red. The indicator line of the sagittal slice appears
in the axial, coronal, and 3D windows.

4.2 How to Adjust the Planes

 Free adjustment of the view by moving the center of the crossed planes
To move the center of the view axes intersection, put the cursor on it, then left-click and
drag. The intersection of the view axes will move within the given plane. This movement
will be synchronized with the change in slice depth in other MPR windows.

Hint Use the "head" icon in the corresponding window to see the orientation of scans

 Quick adjustment of the view by clicking the desired point

To move the center of the crossed planes, put the cursor on the desired position and
double left-click on it. The center of the axes intersection will move to the selected point
immediately.

 Quick adjustment of the view by clicking the implant image

The double left-click on the implant image enables users to set up the coronal axis in the
same position with the implant axis and move the center of axes intersection to the
implant reference point.

 Adjustment of the oblique view (plane rotation)

Since the maxillo-facial region is difficult to evaluate in standard MPR: axial, sagittal and
coronal planes, oblique views become very important in analyzing and planning medical
image data on a computer.
To rotate the plane, put the cursor on the plane line of the corresponding plane, left-click,
hold and rotate it. The plane will rotate around the center of the crossed planes. By
adjusting the only one plane, the other two views in oblique multi-planar will be
generated automatically.

 Parallel movement of the planes

To provide the parallel movement of the plane, put and hold the left mouse button on the
bulky part of the indicator line of the plane and drag it.

 Move the plane by scrolling the mouse wheel

Put the cursor on any point of the MPR window, and then scroll the mouse wheel.

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  Zoom in/out 2D/3D objects
Zoom in/out the views by holding down the right mouse button and moving the mouse
forward or backward.

 Moving 2D/3D objects

To move the object, press and hold down the mouse wheel, then move the object within
the selected window.

 2D/3D Image rotation

To rotate the image, put the cursor on any point of the desired window, press and hold
down the left mouse button and rotate the object.

4.3 3D Rendering Window (Volume)

The 3D volume rendering view can be used to visualize large volumes of data generated
by CT/CBCT scanners in three-dimensional space in aim to simplify the spatial
orientation and object placement control.

Use the icons located at the top left window corner to switch between MIP mode
(Maximum Intensity Projection) (1) and ISO mode (Isosurface) (2).

Use slider (3) to adjust the image opacity threshold.

Click on the top right corner (4) of the 3D Volume Rendering Window to maximize or
minimize it.

To switch On/Off (5) the visualization of the DICOM, STL surface, nerve, crown, implant,
measurements, surgical guide or axes click on the corresponding buttons.

Settings menu of the 3D Volume Rendering Window (6):

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Use the threshold slider (A) to change the density of the bone in ISO mode. To switch
On/Off the visualization of the implant, sleeve, drill or abutment click on the
corresponding buttons (B). To adjust the STL surface, Objects opacity threshold settings,
drag slider right to increase opacity or left to make the object(s) more transparent (C).
Axis planes visualization settings (D). Switch between "Planes" (E) and "Axis" (F) to
change the orientation line view. The software can be switching between low, medium
and high-performance graphics settings, depending on the customer PC graphics card
processor capacity (G).

4.4 Panoramic Mode

Serves for general review of the maxillofacial region and allows users make expanded
evaluation of the implant(s) position

The Panoramic Curve identifies the dental arch position.

The best area where to place the curve is in the half of the length of teeth roots,
Hint
where the canals are going to be good markers for the curve tracing

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To edit or create the panoramic reconstruction of the CBCT/CT scan click on the
"Switch to PANO mode" button (1)

Before starting to edit or trace the panoramic curve, select the Axial Window (2)
containing the dental arch of the upper or lower jaw.

To edit existing panoramic curve move the dots by clicking with the left mouse button on
each yellow dot (3) and dragging it into the right position.

To trace a new panoramic curve, click on the "Add Panoramic curve" button (4)

Put the mouse cursor over the image and draw new panoramic curve using the left
mouse button by placing points one after another on the arch, then double-click to finish
tracing. In case of misplacement, move the dots by clicking with the left mouse button on
each yellow dot and dragging it into the right position.

The Indicator Line (5) of the panoramic slice appears in the axial and in panoramic
window. Put the cursor on the Multislice Window (6), scroll the mouse wheel to move
the indicator line along the panoramic curve to see the desired cross-sectional slice(s).

Quick adjustment of the view. To move the indicator line, put the cursor on the
Hint desired area in axial or in panoramic view and double left-click on it. The
indicator line of the panoramic slice will move to the selected point immediately

To adjust the inclination of the cross-sections in the panoramic view click on indicator
line and tilt it. The numerical value of the angle of inclination (7) will appear near the
indicator line.

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 The angle of inclination will be correct only if the occlusal plane of chosen jaw is
Note!
parallel to axial plan

Click and drag the slider in Panoramic Window to change the panoramic curve
thickness (8).
The default settings for Multislice window (6) assume three separate cross-section
images with distance increment of one millimeter. The number of slices can be
increased to five and reduced to one (9).

Settings menu of the Panoramic Window (10):

To adjust the image opacity threshold, drag slider left to increase opacity or right to
make the image more transparent (A). To adjust the Crown(s) opacity threshold, drag
slider right to increase opacity or left to make the crown(s) more transparent (B). To
switch On/Off the visualization of the implant (C), sleeve (D), drill (E) or abutment (F)
click on the corresponding buttons.

Control panel of the Panoramic Window (11):

"Add Panoramic Curve" button

Click on the Panoramic View list button to choose initial or created panoramic
view(s)

Click on the button to switch between Narrow or Wide mode

Click on the button to add the panoramic image to Surgical Protocol

"Delete Panoramic Curve" button

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4.5 Rotating Slice Window

Click the "Open Slice" button on the Tool Panel to open the Rotating Slice
Window (1)

The main purpose of the Rotating Slice View is final control and ability to make a
precision correction of the implant and sleeve position.
To rotate the image around the Implant axis, put the cursor on any point of the Rotating
Slice window and scroll the mouse wheel or click and drag the slider on the right part of
the window (2).

4.6 Buttons and Basic Functions

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4.6.1 INFO Panel

The INFO panel displays information on the customer name, customer email address
and registration number, patient's name, patient's date of birth and gender, CT scan
data.

4.6.2 Tool Panel

The Tool Panel basically consists of buttons customer needs to manage the case, set
up view, make a measurement, purchase exports, etc.

Click the New Project / Load DICOM button to upload DICOM data

Click the Open Project button to open the existing project

Click the Save Project button to save project

Click the Open Recent Projects button to open the list of the recent
projects

Click the Cloud Service button to manage messages

Click the Save or Send to cloud button to save the created project to
cloud or share it with others

Click the Edit Notes button to note an information

Click the Undo button to cancel the last action

Click the Redo button to reverse the last Undo. Used only after Undo.

Click the Switch to MRP mode button to

Click the Switch to PANO mode button to edit or trace the panoramic
reconstruction curve

Click the Open Slice button to open the Rotating Slice Window

Click the Reset Views button to reset view settings to default

Click the Take Snapshot button to take a snapshot

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 Click the Measure Distance button to perform distance measurement

Click the Measure Angle button to perform angular measurement

Click the Purchase Exports button to order and purchase the export
packages

Regular and Time-limited exports balance

Help button opens app-specific help sections or links when clicked

Click the Settings button to open the Settings Menu

Click the Order Form button to fill out the digital order form

Click the Quick Pass button to send the current project to previously
specified email address

4.6.3 Settings Menu

This menu allows setting the preferences for the software.

The following settings can be set from this page:

Interface, language, and user

settings

There is an option to register a

new user or delete current user

When collision function is

selected, the software checks
the collisions of the objects
automatically. If collision is
detected, the triangular sign
"Attention" will appear

The implant's or pin's safety

zone border intersects a nerve

The implant's safety zone border

intersects another implant

The sleeve intersects a scan

STL surface border

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MPR View settings
Outline thickness and slice width
adjustment

Panoramic View settings

Distance between cross slices
adjustment

Library update and Initial V-

factor settings

Surgical Guide settings

See chapter "Surgical Guide"
for a more detailed explanation

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Paths settings
Specify the path for placing the
library folder using the "Data
Directory" tab.
For example:
C:/Users/USERNAME/AppData/
Roaming/ImplaStation

Cloud Service and Quick Pass

Email settings

Additional settings

System and User Info

(example)

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4.6.4 Visualization Tools

Click the button to enable or disable the visualization of the DICOM

Click the button to enable or disable the visualization of the STL surface

Click the button to enable or disable the visualization of the Nerve Tracing

Click the button to enable or disable the visualization of the Crown

Click the button to enable or disable the visualization of the Digital Implant

Click the button to enable or disable the visualization of the Measurements

Click the button to enable or disable the visualization of the Surgical Guide

Click the button to enable or disable the visualization of the Axis

Click the button to enable or disable the visualization of the Patient Data

4.6.5 Tab Panel

Tab panel helps users navigate through the patient's case

DICOM management

STL surface management

Nerve tracing

Crown design

Digital Implant, Sleeve, Drill, Abutment management

Anchor Pin management

Surgical Guide design

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5. INPUT DATA (DICOM)

The first step of the planning process is to upload a CT/CBCT dataset of the patient.
The software does not modify or compress the input DICOM data during their upload,
usage or export. DICOM Conformance Statement for ImplaStation is available for
download here: https://implastation.com/documents/upload/dicom-conformance-
statement.pdf
Click the New Project / Load DICOM button which is a way either to import a
dataset from CD or import dataset from a selected source

In the appeared window to

download data, select any object
from the following:

- folder with DICOM Data

- multi-slice DICOM file
- single-slice DICOM file, one
from the set
- DICOMDIR file

Then click on "Open"

To see DICOM-files without extension choose "All files" option.

Ensure to select the correct study and series by comparing them with the patient name
in the CT/CBCT data selection dialog. After you have uploaded the relevant dataset, it is
displayed in the processing window.

To adjust the visualization of the uploaded CT/CBCT dataset drag the corresponding
slider to adjust the image opacity threshold (A), switch between MIP mode (Maximum
Intensity Projection) and ISO mode (Isosurface) (B). With the cropping tool, remove
disturbing or unrelated parts of the CBCT/CT scan by left-clicking, holding and dragging
the purple cropping box inside the windows and area outside the box will be deleted (C).
In case of DICOM is displayed with an incorrect orientation upside down, turn it so that
the Maxilla is on top and the Mandible is on the bottom using rotation slider (D). Then
click "OK".

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5.1 DICOM "Cutting"

The 3D and 2D visualization of the CT/CBCT scan of the patient may be "cut off" by an
overlay of the dark mask on a selected area of the DICOM. Created masks can be
turned on and off to hide and display fragments of CT/CBCT. This feature is most in
demand for working with 3D rendering.
Optionally maximize the "Volume" window. Setup the 3D image position. Click on the
"Cut" button in DICOM directory in the right part of the screen. To identify the area on
which the DICOM mask is going to be cut. Draw the borderline by placing points one
after another around the cutting area. Continue to draw the curve that goes back to the
starting points and then double-click to finish selection.

Then either click on the "Cut inside selected area" button to cut inside or click on "Cut
outside selected area" button to "cut" outside.

Press the "Save" button to save the created DICOM mask and mask name will appear in
the list in DICOM directory on the right part of the screen. Optionally, it is possible to
change the name of the saved DICOM mask by pressing the "Edit Title" button (A).
During the design process choose any saved DICOM mask by left-clicking on it.

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5.2 DICOM to STL Conversion

Click on the "Convert to Surface" button to start the conversion process of the DICOM
file to STL surface. Adjust 3D rendering threshold by clicking “+” and “-“ buttons (B) (see
next page).

Adjust the size and position of the working area which is outlined by a purple line.
Expand or compress the working area by left-clicking, holding and dragging the purple
converting box of the working area. To rotate the whole working area left-click, hold and
drag the red, yellow and green marks. To move the whole working area left-click, hold
and drag the square located at the central part of the converting box.

Click on the "Convert DICOM to Surface" (A) button and If everything is OK click on (C)
"Move to Project” button.

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 The final view of the converted surface depends on the pre-adjusted 3D-
Note!
rendering threshold

5.3 DICOM Segmentation

The "Segmentation" tool can be used in panoramic mode for bone segmentation
(cross-sectional view), and in MPR mode (axial view) for segmentation of bones and
teeth. The Segmentation tool is intended for slice reconstruction of the segmented area.
Each slice can be edited manually.

Switch on the "PANO mode", set up the panoramic curve and adjust the view of the
working cross-sectional area in Multislice window.

This example of using "Segmentation" is one possibility, among many. Click on the
"Segmentation" button to start the segmentation process of the DICOM file. Setup the
brightness and contrast. Unmark the "Use mask" checkbox.
Adjust the size and position of the working area which is outlined by a purple line.
Expand or compress the working area by left-clicking, holding and dragging the squares
located at the corners of the working area, or just move the whole working area left-
clicking, holding and moving the square located at the central part.

25
Click on "Receive segment" button. The appeared green contour in Multislice window
outlines the structures of the patient CBCT scan to be segmented.

There are two ways how to draw or adjust the boundaries of the zone to be segmented.
Place the round cursor into the green zone or outside the green zone, click and hold the
left mouse button and the software automatically fill in or fill out the segmented area
gradually oriented on the bone density.
Or place the round cursor into the green zone or outside the green zone, click and hold
the right mouse button and push off the borders of the segmented area manually. To
maximize or minimize the size of the round cursor just scroll the mouse wheel forward or
backward. Finalize the slice segmentation by left-clicking on any part of the Multislice
window outside of the purple working zone. The green color of the segmented area will
be changed to the yellow one.

To proceed with the next area to be segmented, just scroll the mouse wheel outside of
the purple working zone and repeat the steps above.

26
Step by step mark the entire volume of the required bone block. Press the "Convert"
button to build a surface from selected contours. Check the result and safe the
segmented block into the project by clicking the "Move to Project" button.

5.3.1 Options

The software allows you to segment DICOM using "MPR mode". This option is most
preferred for tooth segmentation. The difference with the method described above is that
the process is carried out in the Axial window.

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For the accurate and precise segmentation of the small structures such as a tooth and
root(s) use the Mask mode. Mark the "Use mask" checkbox (A). This feature controls
the contour size changes of the segmented zone within the value in pixels set by the
user. For example, if the number of pixels in the corresponding window (B) is marked as
3, then the difference in the size of each subsequent zone will not exceed ±3 pixels. To
start tooth segmentation, mark the "Use mask" checkbox, choose the number of roots in
the corresponding window (C) and proceed with the segmentation process described
above.

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6. INPUT DATA (STL)

Surface scans of the patient's mouth can be obtained from 3rd party intraoral scanner or
any 3D lab scanner, provided in an open .stl or .obj format.
Optionally you can scan the stone model of the patient jaw using CT/CBCT scanner and
convert obtained DICOM file to STL surface (see APPEX B - Dual Scan Technique).
The accuracy of the double scanning method is doubt.

Click the STL Surfaces button in the tab panel on the right part of the screen.

Click on "STL+" button and select the patient STL file on your computer. Press OPEN
and wait for it to finish loading.

If the amount of triangles in an STL file is exceeding a threshold (400000

Note! triangles on default. May be adjusted in the settings menu), the software would
propose to reduce the number of triangles in the file

 Alignment.
Mark the "Align to DICOM or to another STL file" checkbox and press OK to start an
alignment process. Or Mark either the "Put to the center of coordinates" checkbox to
place the STL model at the center of coordinates, or mark "Put to original
coordinates" checkbox to place STL model at the original coordinates. The "Put to
original coordinates" is the most convenient mode to import several STL surfaces
previously mapped together in the third-party CAD programs.

Mark the "Align to DICOM or to another STL file" checkbox and press OK. Bring the
two images into view so that they are similar.

Pick a point on DICOM surface as a landmark by left-clicking, then click a point on the
corresponding region of the STL surface. Select at least 3 equal regions and click on the
"Align to selected object" button.

29
To adjust alignment manually, click on STL surface center (the square point which is
marked in color of corresponding STL surface) and drag it or click on the STL surface
borderline and tilt it.

 Click on the "Group" button in the Tab Panel on the right part of the screen and
select two or more STL file in the appeared window to group them for further design and
alignment and press "OK".
The main purpose of this feature is an ability to move selected and grouped up STL
objects together. The mutual position of the grouped up STL surfaces remains
unchanged.

 To realign STL files or STL and DICOM files press on "Align" button.

 Click on "Fix" button to repair STL file.

This feature enables the software to analyze STL files automatically and repair the
various defects in 3D meshes, such as holes, self-intersections.
In case you are not satisfied with the result, you may try to fix the STL file again by
clicking the "Fix" button. But the upshot is you get the repaired file in an instant.

30
ATTENTION! Using this tool, unclosed surfaces can be closed if no errors are found

 To export STL file choose the STL file to be saved in the list of STL mode, then click
on "Export" button. In appeared window either press "OK", or select additional objects
(Implant(s)/Pin(s), Abutments, Sleeve(s), Drill(s))to be combined and saved with STL
file), then press "OK". Please be advised your account will be charged for one
export.

 To reduce the number of triangles in the STL file mesh, in other words, to simplify the
file, click on the "Edit" tab, then on the "Simplify" button.

 To split STL, click on "Split" button in “Edit” submenu and draw the split line, then
click on "Split Surface" button and add the SLT file to the project clicking "Keep BLUE
surface" button to save blue-colored surface to the project, or click on "Keep RED
surface" button to save red-colored surface to the project.

 Click on "Edit" button, then choose the “Remesh/Change” line, then click on the
"Spheres" button to open a menu. Define the planning area by setting the green sphere
in the center of the planning zone either using the MPR view or the 3D view. The center
of the sphere glides over the STL surface in a 3D rendering view.
Once the planning zone is defined, adjust the size of the sphere by scrolling the mouse
wheel.
The sphere can be used for both purposes - to add "tissue" to the STL surface by
clicking the left mouse button or to remove the corresponding selected part of the STL
surface by clicking the right mouse button.

31
There is an option to press and drag the cursor to draw a strip of spheres. If necessary,
after drawing apply function "smoothing".

Most of the STL surfaces can be split, but small defects such as through holes
Note!
can trip up the split process

 To cut the STL file, maximize the "Volume" window. Setup the STL surface
position. Click on "Edit" button, then click the "Cut" button. To identify the area
on which the STL surface is going to be cut. Draw the borderline by placing points
one after another around the cutting area. Continue to draw the curve that goes
back to the starting points and then double-click on this line. Or use a round or
square frame with a variable size to highlight the desired cut-off area. Then click
on the "Cut Inside" or "Cut Outside" button.

Note! The direction of the cutting is perpendicular to the plane of the screen

 To invert the working surface of the STL file, choose the STL file to be inverted in the
list, and then click on "Edit" button, then click the "Invert" button.

 To "remove" (actually the software makes a black mask) the STL volume from
DICOM file, select the appropriate STL file, click on "Edit" button, then click the "Delete

32
from DICOM" button and cut the volume bounded by the STL-surface from the DICOM
image.

 To smooth segmented STL file (as well as any other preloaded STL) choose the STL
file to be smoothed in the list of STL mode, and then click on "Edit" button, then choose
the “Remesh/Change” line, then click on the "Smooth" button. It is assumed either to
smooth the local part of the surface, using the green circle cursor. Smoothing intensity
can be adjusted. Using “Smooth all” button smooth the entire surface.

33
  Click on "Edit" button, then click on the "Boolean operations" button and in the
appeared window choose the type of Boolean operation: Unite, Intersect,
Subtract. To merge Object A (current STL) and Object B (STL Surface,
Crown/Tooth, Surgical Guide) press "Execute" button.

New STL surface will appear in the STL list.

34
Note! Boolean operations are performed correctly only with “closed” surfaces

 To expand or shrink the surface by a certain value in millimeters, click on "Edit"

button, then select the offset value in the window opposite the "Offset" button, then
click on the button.

35
7. NERVE CANAL TRACING
Select MPR mode. Setup the slice planes to visualize nerve canal clearly in axial, cross-
sectional and sagittal view.

Click on "Nerve" button in the workflow panel on the right part of the screen

Click on "Draw new Nerve" button and cursor is going to be a red spot. Trace nerve
canal using the left button of the mouse points one after another from frontal part to
distal part in the Sagittal window.
Or trace the nerve canal by clicking and scrolling through the Cross-sectional view.
Complete the operation either by double-clicking the left mouse button or by clicking the
"lock" button in the nerve tracing menu panel.

Make sure that the nerve is correctly traced. Always maintain an appropriate safety
Warning!
distance to the nerve canal
The pathway of imaged nerves is for display only, location accuracy of the traced nerve is
Warning! not tested, and pathways of imaged nerves can not be used as sole information for the
clinician to make clinical decisions

36
8. VIRTUAL CROWNS PLACEMENT

Select MPR mode. Set up the slice planes to visualize the tooth/teeth position to be
planning in axial, cross-sectional and sagittal view.

To add a virtual tooth click on "Crown" button in the workflow panel on the right part of
the screen. Click on "Place new Crown or Tooth" button. In appeared "Select
Position" window select the crown or tooth mode, click on the desired tooth in the
virtual OPG, and the virtual crown or tooth is going to appear in the pre-set area.

To change the tooth position in axial, cross-sectional and sagittal view just click on and
hold central square and drag it or click on and hold the line tilt it.

37
To change the size of the tooth/crown, use "Scale" slider below the "Place new Crown or
Tooth" button. To edit a crown or tooth, press the "Edit" key, and in the window that
appears, select the function to change. All the presented change functions are described
in the STL chapter.

To change the tooth position in 3D mode, maximize the "Volume" window, click on the
tooth. The green round line is going to appear. Left-click, hold and drag this green line to
tilt the tooth. Right-click, hold and move the mouse forward to increase the tooth size or
move the mouse back to decrease tooth size.

Click on "Lock On/Off" button in the "Crown" tab panel or go to the next step.

38
9. IMPLANT PLANNING

The software allows users to perform implant planning using Panoramic, MPR or
Rotation Slice mode.
There is a concept, which software uses to calculate the position of every single element
such as an implant, drill, and sleeve.

The general idea of the concept is the

implant is the primary object. The drill tip is
connected to the implant apex (A) and
occlusal surface of the sleeve is connected
with a drill stopper surface (B). And if the
drill length is changed, the sleeve position
will be changed equally increasing and
decreasing sleeve offset (C)

Select MPR mode. Set up the slice planes to visualize the further implant position to be
planning in axial, cross-sectional and sagittal view.

To add a virtual implant click on "Implant" button in the workflow panel on the right part
of the screen. Click on "Place new Implant" button and at the appeared window, choose
the "implant", "sleeve", "drill" and "abutment" corresponding submenu by left-clicking.

To place an implant that does not show up on the implant library list, click on the
"Implant" submenu, select "Custom Implant" option, choose the implant color and enter
relevant dimensions for "Occlusal Diameter" (D), "Apical Diameter" (d), "Implant Length"
(H) and "Interface Edges (Angles) Count". Mark the "Place as a last Implant" checkbox
to save settings for the next implant(s) to be placed. To restore settings for the next start

39
of the software, mark the appropriate checkbox in the lower right of the submenu
window.

Add the V-factor depth by scrolling the mouse wheel, or writing the number, or by
clicking on the arrows. Increasing or decreasing the value of the V-factor leads to the
drill tip shifts down or shifts up relative to the implant apex.

The same can be performed for custom sleeves. Click on the "Sleeve" submenu, select
"Custom Sleeve" option, choose the sleeve color and enter required dimensions for
"Sleeve Inner Diameter" (d), Sleeve Outer Diameter (D), Sleeve Height (H), Sleeve
Edge Diameter (De), Sleeve Edge Height (He).

Custom Drills. Click on the "Drill" submenu, select "Custom Drill" option, choose the drill
color and enter required dimensions for "Drill Length" (L), "Drill Diameter".

40
Click on the "Abutment" submenu, select "Custom Abutment" option, choose the
abutment color and enter required dimensions for "Collar Height" (Hc), "Abutment Angle"
(A).

Press "OK" and select the tooth position.

To change the implant position in axial, cross-sectional and sagittal view just click on
and hold square mark at the occlusal line of the implant and drag it, or click on and hold
the contour line and tilt it.

41
To change the Implant position in 3D mode, maximize the "Volume" window, click on the
implant. The green and blue round lines are going to appear. Left-click, hold and move
this green line to tilt the implant. Left-click, hold and move the blue line to rotate the
implant.

There are three ways to change the size and type of the Implant:

 Use the quick menu at the left lower corner of cross-sectional and sagittal windows.
Click on "implant" sign, and change the implant diameter and length by clicking on the
"+" or "-" sign.
Click on "drill" sign and change the drill diameter and length by clicking on the "+" or "-"
sign.
Click on the "sleeve" sign to lock offset of the sleeve.
Use the slider to rotate the implant around the central axis.

42
 Go to the menu below the "Place new
Implant" button in the right part of the
screen to change the size of the implant by
clicking on the number and scrolling the
mouse wheel, or writing the number into
the appropriate windows, or using the
arrows.

 Press on "Replace Implant" button and

set the Implant, Drill, Sleeve, and
Abutment settings up

Click on "Lock On/Off" button in the "Implant" tab panel or go to the next step.

To load implant libraries from the server click on "Replace Implant" button and then
click on the "Load From Server" button. In appeared window select the system of the
implant by marking checkbox and press "OK" and the chosen library will be downloaded
into the software Implant list.
The same downloading procedure can be performed for drills, sleeves, and abutments
libraries.

43
Now there is a possibility to use the implant, drill, sleeve, and abutment provided by
manufacturer. (Be advised – some libraries created by backward engineering method)
To place preloaded elements click on the "Place new Implant" button or on the
"Replace Implant" button, in the appeared menu choose the implant manufacturer
name, implant line name, and implant size.

Click on the "Sleeve" submenu, choose the sleeve manufacturer name and sleeve line
name.

44
Click on the "Drill" submenu, choose the drill manufacturer name, drill line name, and
drill size. Set up "V-factor" depth, then press "OK".

Click on the "Abutment" submenu, choose the abutment manufacturer name, abutment
line name, and abutment size and type.

Click on the "Analog" submenu, choose the analog manufacturer name, analog line
name, and analog size and type.

45
Check the implant position and press "Add Drill" to add a final drill to the drilling list.

Click on "Drill" submenu in the right part

of the screen and set up the drill diameter
"D" (A), drill length "L" (B), drill V-factor
(C), the drill spacer "S" (D) is an option to
add the regulated space between stopper
of the drill and contacted surface of the
sleeve to change a position of the sleeve
and decrease the sleeve offset during
digital implant planning.

46
Click on the "Sleeve" submenu in the right
part of the screen and check the name of
the sleeve (A), offset length "O" (B). To
rotate a sleeve click on the slider and drag
it (C) to rotate a sleeve by an angle
multiple of 15, 30, 60, 90 degrees, choose
the rotation angle checkbox "R" and select
one of the four options: 15, 30, 60, 90 (D).
To change the current sleeve, click on the
"Replace Sleeve" button (E).

Click on the "Abutment" submenu in the

right part of the screen and check the
name of the abutment (A), collar height
"Hc" (B) and extension angle "Ae" (C). To
make a rotation of the abutment click on
the slider and drag it (D). To change the
current abutment, click on the "Replace
Abutment" button (E).

47
10. ANCHOR PIN PLANNING

The pin planning using ImplaStation has the same concept as an implant positioning.

Select MPR mode. Setup the slice planes to visualize the further pin position to be
planning in axial, cross-sectional and sagittal view.

To add a virtual pin click on "Pin" button in the workflow panel on the right part of the
screen. Green transparent arrow will appear in Axial and Sagittal windows in an aim to
show the position and direction of the pin.

Click on "Place new Pin" button and at the appeared window, choose the "pin",
"sleeve", and "drill" corresponding submenu by left-clicking.

To place a pin that does not show up on the pin library list, select "Custom Implant"
option, choose the pin color and enter relevant dimensions for "Diameter" (d), and
Length" (H). To restore settings for the next start of the software, mark appropriate
checkbox in the lower right of the submenu window.

48
The same can be performed for custom sleeves and custom drills (see Implant settings
part). Then press the "OK" button.

To change the pin position in axial, cross-sectional and sagittal view just left-click on and
hold square mark at the stopper-contact surface area of the pin and drag it (A), or click
on and hold the contour line and tilt it (B).

49
 Use menu below the "Place new Pin"
button in the left part of the screen to
change the type of the pin or adjust pin
diameter (A) and length (B) by clicking on
the number and scrolling the mouse wheel,
or writing the number into the appropriate
windows, or by clicking on the arrows.

Click on the "Replace Pin" button and set

up the Pin, Drill, and Sleeve settings.

Click on "Lock On/Off" button in the "Pin" tab panel or go to the next step.

To load Pin libraries from the server click on the "Replace Pin" button and then click on
the "Load From Implant Server" button. In appeared window select the system of the
pin by marking checkbox/es and press "OK" and the chosen library will be downloaded
into the software Pin list. The same downloading procedure can be performed for drills
and sleeves libraries.

50
Now there is a possibility to use the pin, drill, and sleeve provided by a manufacturer.
To place preloaded elements click on the "Place new Pin" button or on the "Replace
Pin" button, in the appeared menu choose the pin manufacturer name, pin line name,
and pin size.

Click on the "Drill" submenu in the right

part of the screen and set up the drill
diameter "D" (A), drill length "L" (B), the
drill spacer "S" as an option to add the
regulated space between stopper of the
drill and contacted surface of the sleeve to
change a position of the sleeve and
decrease the sleeve offset during digital
pin planning (C)

Click on the "Sleeve" submenu in the left

part of the screen and check the name of
the sleeve (A). To change the current
sleeve, click on the "Replace Sleeve"
button (B).

51
11. SURGICAL GUIDE CREATION

To start a virtual surgical guide creation click on "Surgical Guides" button in the
workflow panel on the right part of the screen. Click on "Make Surgical Guide based
on Surface" button and at the appeared window setup the STL surface position.

If the direction of the surgical guide is suggested by the

program incorrectly, select the Surgical Guide orientation -
"Maxilla" or "Mandible".

Set up the Surgical Guide settings for printing:

A Gap (mm) (set up an additional compensation value for
the expansion or shrinkage of the guide material during the
printing process. The settings of this parameter avoid
difficulties during the process of placing and removing the
surgical guide, and are necessary to compensate for
scanning errors or other aggravating factors.);
B Thickness (mm) (surgical guide wall thickness settings);
C Sleeve Support (mm) (set the diameter of the sleeve
supporting block);
D Pin Sleeve Support (mm) (set the diameter of the pin
sleeve supporting block);
E Sleeve Safety (mm) (set the diameter of the dental
handpiece head safety zone around the sleeve);
F Sleeve Gap (mm) (set the positive radial offset between
a sleeve and surgical guide);
G Side Angle (degrees) (set the value of the angle of the
slope of the guide edge).

52
Default settings can be changed in the Settings Menu.

To identify the area in which the Surgical Guide is going to be created, draw the
borderline by placing points one after another around the Surgical Guide area. Continue
to draw the curve that goes back to the starting points and then double-click on this line
or click on the “Draw Curve” button.

Before generating the guide, set up the insertion direction from the view
perpendicular to the screen. So set the view to provide minimum undercuts, and
Note!
then click on the "Preview Guide" button and software will go ahead and create
the preview model of the surgical guide.

Click the "Edit Guide" button to open the Surgical Guide Edit Menu.

53
Click “Cut Holes” button (A).

To cut viewing windows either click on the

round window button or click on the square
window button, set up the size of the
window by scrolling with the mouse wheel
(C-D).
The cursor is going to be round or square
shape cutter, move the cursor over the
STL surface of the generated surgical
guide then left-click to make a hole.

Click “Place Support” button (A).

To add a round/square support bar from

the menu either click on the round button
or click on the square button, set up the
size of the support bar by scrolling with the
mouse wheel (C-D).
Place a support bar on the guide surface
and modify it by using the points for
rotation and size adjustment.

54
Select the “Place Label” button (A).

Type in the desired text in the label field.

Modify the desired label text depth (D) by
scrolling with the mouse wheel.
To add a label to surgical guide move
cursor over the guide and left-click where
you wish to place tag. Click on the
"Concave" (B) or "Convex" (C) checkbox
to modify the way a Label imprints on the
surgical guide surface.

Check the surgical protocol by clicking the "Surgical Protocol" button in the Surgical
Guide menu on the right part of the screen.

Check Surgical guide settings and modifications then click "Make Guide" button to
achieve the final view of the generated guide.
To save created Surgical Guide on your computer press "Move Guide to Project", then
in the appeared window, click "Yes".

Note! Paid option. One credit will be charged from your account

55
To cut a Surgical Guide, maximize the "Volume" window. Setup the Surgical Guide
surface position. Click on the "Cut selected Surgical Guide" button to cut only Surgical
Guide.

Click on the "Cut selected Guide and it base Surface" button to cut Surgical Guide and
STL surface.

To identify the area on which the Surgical Guide surface is going to be cut. Draw the
borderline by placing points one after another around the cutting area. Continue to draw
the curve that goes back to the starting points and then double-click on this line. Then
click on the "Cut inside" or "Cut outside" button.

Note! Set up the direction of the cutting from the view perpendicular to the screen

To copy generated Surgical Guide to STL surfaces list click "Copy to STL Surfaces"
button in the Surgical Guide menu on the right part of the screen.

56
11.1 Surgical Guide Based on Prosthesis

To start the creation of the surgical guide based on the denture click on the "Surgical
Guides" button in the workflow panel on the right part of the screen. Click on the "Make
Surgical Guide based on Prosthesis" button and at the appeared window setup the
STL surface position. Select the Surgical Guide orientation - "Maxilla" or "Mandible". Set
up the Surgical Guide settings for STL printing.
Before generating the guide, position it taking into account that the pass of insertion of
the planning surgical guide is perpendicular to the plane of the screen. Then click on the
"Generate Guide" button and software will go ahead and create the surgical guide.

To get file of the Surgical Guide saved on

your PC press "Yes" in the appeared
window, one credit will be charged from
your account, then click on "Export" button
(A). To get file of the Surgical Protocol
saved or printed, press "View Surgical
Protocol" (B).

57
12. SURGICAL PROTOCOL

The ImplaStation creates a surgical protocol together with the surgical guide based on
virtual implant planning, sleeve(s) position and selected surgical drill sequence.

Click the "View Surgical Protocol" button in the right part of

the screen to open the Surgical Protocol Window

The following image shows an example of a surgical protocol.

The surgical protocol is available per implant providing detailed information together with
the images of the planning view. Adjust the guide position as you need. To get more info
select the option "Show implant page".

To add a panoramic image to the Protocol select the option "Add to surgical protocol"
see Page 15 (11).

58
 WARNINGS AND PRECAUTIONS

There are no chemical, physical, electrical, mechanical, electromagnetic and biological

hazards to the ImplaStation software.
However, there are several warning functions designed to remind the user of his legal
responsibility to verify implant planning stages and results.
 INDICATIONS FOR USE

The ImplaStation software must be used in accordance with their

Warning!
accompanying instruction for use

Warning! This device is not tested on the pediatric patient population

Prior to working with software, please make sure to have received

Warning! appropriate training and instructions in software operation. Prodigident offers
regular online webinars for ImplaStation which is open for all users

Correct design of the surgical guide lie within the sole responsibility of the
Warning!
user

3D manufacturing is out of ImplaStation software control, depends on many

Warning!
external factors and lie within the sole responsibility of the user

The manufactured surgical guides for implant placement are classified as

medical devices by the FDA (under 21 CFR 872.3980). Surgical guides are
Warning! subject to legal requirements such as registration and listing as a
manufacturer of medical devices, validation of production equipment,
processes and quality system regulations

In the US. 3D printed surgical guide is a medical device to be manufactured

Warning!
at an FDA registered and listed manufacturing location

 DICOM

The user is solely responsible to ensure that the quality of the loaded patient
Warning!
CT/CBCT data is sufficient for proper planning the case

The production of CT/CBCT scans lies within the full responsibility of the
Warning! clinicians or appropriately qualified personnel. The CT/CBCT scanner should
be maintained within original manufacturer specifications

59
 NERVE CANAL

Make sure that the nerve is correctly traced. Always maintain an appropriate
Warning!
safety distance to the nerve canal

The pathway of imaged nerves is for display only, location accuracy of the
Warning! traced nerve is not tested, and pathways of imaged nerves can not be used
as sole information for the clinician to make clinical decisions

 IMPLANT PLACEMENT
During implant placement, please assure that an implant/pin does not collide
with an existing implant/pin, tooth root(s) or nerve canal. A collision of the
Warning!
implant/pin with another implant, nerve, or any other main anatomical
structure can cause severe damage

The user must be able to recognize the triangular sign "Attention" to detect
warnings such as “Collision between implant/pin and implant/pin”, "Collision
Warning!
between sleeve and scan STL surface", and "Collision between implant/pin
and nerve canal"

Using the STL files of implant and other elements libraries created by
Warning!
reverse engineering are made at the user's risk

 SURGICAL GUIDE

Make sure that created STL file of the surgical guide or produced surgical
Warning!
guide is intended to be used only by trained qualified dental practitioners

 ALIGNMENT

Make sure that CBCT/CT and STL surface scans are well aligned in all
Warning!
relevant areas, particularly in the implant placement area

60
ANNEX A - How to evaluate the quality and accuracy of alignment?

The software enables users to overlay and align DICOM visualization to the STL surface
by picking points on both surfaces as a landmark (see part 6, p.28).
There is a tool to correct an alignment manually in MPR or Panoramic mode. Dragging
the scan with the square point (A) or rotating the scan using the control point on contour
line (B) of the scan provides your movement to one dimension in Axial, Coronal, and
Sagittal views (see picture).

The aim is to get the contour of the STL surface scan to coincide with the corresponding
object on the CT scan. Teeth are a good landmark for alignment.

Example of the alignment:

61
ANNEX B - Dual Scan Technique

Full Digital Workflow for the Treatment Planning of an Edentulous Patient with
Guided Surgery using Dual CBCT/CT Scanning Technique.

Definitions:

Dual Scan Technique (DST). The dual scan (dual CBCT scanning technique) is the
term used when a dental appliance, such as a set of dentures, is superimposed over the
patient CBCT/CT scan.
Scan Appliance is a denture with temporary radiopaque markers that are applied
directly to the inside and outside of the denture.
DST Patient CBCT/CT Scan is a head CBCT/CT scan of the patient wearing the
denture prepared with temporary radiopaque markers. The patient’s dentures should be
in occlusion when the scan is taken.

ImplaStation Dual Scan Technique Workflow:

1. Create new project:

You can either import an existing project (see section 4.6.2 - Tool Panel) or create a
new project.

2. Import Patient’s CBCT/CT scan data:

62
 Click the New Project / Load DICOM button to upload the patient’s DICOM
data (see Chapter 5. Input Data (DICOM)).

3. Import Scan Appliance DICOM data:

To use the Dual Scan Technique, you need to import DICOM data of the Scan
Appliance(s) with radiopaque markers.

Click the STL Surfaces button in the tab panel on the right part of the
screen.

Click on button and select the Scan Appliance DICOM file on your
computer. Press “OPEN” and wait for it to finish loading.

4. Segment/Convert of the dental appliance:

Choose the action you plan to apply to the downloaded file. The software offers the
following options: Segmentation or Conversion of the dental appliance data (DICOM)
into the surface (STL).

To convert Dental Appliance scan data, follow the instruction described in Chapter 5.2 –
“DICOM to STL Conversion” of this User Manual.

To segment Dental Appliance scan data, follow the instruction described in Chapter 5.3
– “DICOM Segmentation” of this User Manual.

Once DICOM is converted/segmented into STL set, you can proceed to the alignment of
the CBCT/CT scans.

5. Align Scans:

Check the box "Align to DICOM or to another STL" and click OK to start an alignment
process. Or Mark either the "Put to the center of coordinates" checkbox to place the STL
model at the center of coordinates or mark the "Put to original coordinates" checkbox to
place the STL model at the original coordinates.
Use the sliders to adjust the density of the bone/denture. Place points on the radiopaque
markers scan in the left 3D pane and corresponding points on the Surface Scan in the
right 3D pane. Then click the "Align Surface to selected object" button.

63
To adjust alignment manually, click on the STL surface center (the square point which is
marked in color of corresponding STL surface) and drag it or click on the STL surface
borderline and tilt it. (See Chapter 6. - INPUT DATA (STL)).

6. Create a soft tissue surface (Split and Invert):

Once the CBCT/CT scans are aligned, you can proceed to the soft tissue surface
detection step. Open the STL submenu, click the “Edit” button, then click the “Split”
button, choose “Free slit” option.
Set up the 3D object position, click on the "Draw Curve" button (B) (see picture below),
the application switches to drawing mode, and draw the borderline by placing points one
after another around the area of interest.
To split the surface into two objects you need to click on the Split Surface button (C),
and then add the SLT object to the project by clicking the "Keep RED surface" button (E)
to save a red-colored object. Click the “Invert” button, then click the “Quit” button and
save new STL surface.

7. Perform Implant planning:

64
 Once the soft tissue surface is created, you can proceed to the Implant planning,
follow the instruction described in Chapter 9 – “IMPLANT PLANNING” of this User
Manual.

8. Create the surgical guide:

Follow the instruction described in Chapter 11. SURGICAL GUIDE CREATION.

9. Create the surgical guide based on prosthesis

Optionally you can proceed to the surgical guide creation exactly after the CBCT/CT
scans alignment step. (see Section 11.1 Surgical Guide Based on Prosthesis).

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ANNEX C - How to anonymize your project file.

To anonymize your Project file, click the "Save" button. The button is located in
the upper left-hand corner of ImplaStation's interface.
Under the "Save File" submenu, decide on your save location. In the "File Name" field,
type in your preferred Project file name (do not use patient name in project file name).
Click "Save" to save your file.

Under the next "Save Project" submenu, click "Anonymize Project" (A) and "OK" (B).

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ANNEX D
Cloud Service.

A-D.1 Inbox.
Click the “Cloud Service” button. It's in the top-left corner of the ImplaStation's
interface. Doing so prompts a "Cloud Service" window.

Refresh

Open project

Forward project file

Delete file

Restore deleted file

Contacts

Add new contact

Find the "Received" tab. "Received" is located in the upper left-hand corner of the Cloud
Service interface. Double-click a received project file to open the project or select
received project file and click .

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Find the "Sent" tab. Click a “sent” project file to open the project, you sent before.

Find the "Private" tab. Click an “Anonymous” project file to open the anonymous project.

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Find the "Basket" tab. Deleting project files from your inbox doesn't permanently delete
them immediately - they'll move to the "Basket" folder where they'll remain for 90 days
before being deleted automatically.

A-D.2 How to send a case.

Click . It's in the top-left corner of the ImplaStation's interface. Doing

so prompts a "Contact List" window.
Enter/select your recipient's email address. In the "Add Contacts" text box, type in the
email address or select the existing recipient's email in the list.

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A-D.3 How to save in the cloud.

Saving your Project File in the cloud lets you access them from anywhere. To save

Project File online with Prodigident Cloud, click make a brief

description of the case and click OK.

Prodigident Inc. uses AWS's utility-based cloud services to process, store,

and transmit encrypted Project Files.
Warning! AWS's utility-based cloud services stores data (Project File) for at least one
year after data generation completes. Prodigident will send user an alert
email one month before removing data from the server.

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ANNEX E
Cybersecurity Hygiene

The ImplaStation software does not store patient personal data, medical information, PII
and non-PII data directly. All the data is stored on the user PC. User is responsible for
data protection on the user side.

To protect data against loss or unauthorized use, several security mechanisms have
been implemented in ImplaStation:
 Restrict user access to the storage media, operating system by setting up a
strong user password;
 Create a unified way of working. Installation / Upgrade of product security
patches and software packages by an authorized user and/or possibly authorized
HDO or Dental Lab staff.
 Configure the operating system to prevent further access to the system by
initiating a session lock after 10 min of inactivity or upon receiving a request from
a user;
 Configure the operating system to restrict the access to security features of the
PC;
 Use data encryption to secure Patient data, Project Files, Drilling protocols on
your computer system and storage media;
 Use the anonymization function to protect patient personal data if required;
 Backup your data regularly and always backup before updating or uninstalling the
software;
 Use anti-virus software, firewall.

.
ANNEX F
Implant Libraries for ImplaStation

ImplaStation supports more than 35 implant library providers that let customers precisely
plan the implantation. Now customers have access to the next original implant system
libraries:

Bio3 Implants Gmbh; Adin Dental Implant solutions; Alpha Dent Implants GmbH; ALPHA
BIO TEC. LTD.; ARGON DENTAL VERTRIEBS; B&B Dental; B.T.I. Biotechnology
Institute; BEGO Implant Systems; BioHorizons Implant Systems; Bredent GmbH & Co;
BTK (Biotec Srl); CAMLOG Biotechnologies; Cortex Dental Implants Industries Ltd.;
COWELLMEDI IMPLANT; Global D; Medentis Medical GmbH; Inno Implant RU;
INNOBIOSURG CO; Iterum – Dental Implants & Equipment Ltd.; Kentech Co.; Kopp
Sistema de Implante Dental; Lasak; LEONE spa; LYRA ETK group; BrainBase
Corporation; Neoss LTD; NDI Medical; Oxy Implant Dental System; PSM Medical
Solutions; SGS Denta; Southern Implants; STECO; Sweden & Martina; T.A.G. Medical
Products; ROOTT IMPLANT SYSTEM; TRI; VulKan

The following libraries of implant and other elements created by reverse engineering or
otherwise are intended for software functional testing purposes only:

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Ankylos; Dentsply Sirona; Dentsply Astra; Dentium; DIO; i3Lab; Implantium Fixture;
JDentalCare srl; MIS; NeoBiotech; NOBEL; Osstem implants; Straumann; ICX-
Magellan; Megagen; Biomet 3i

Prodigident Inc. disclaims and makes no representation or warranty with respect to the
Implant and other elements libraries created by reverse engineering or otherwise, or any
portion thereof, and notwithstanding anything contained to the contrary herein assumes
no liability for any claim that may arise with respect to such Implant and other elements
libraries or Customer's use or inability to use the same.

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REVISIONS

Summary of Authorized
Revision Date Section Paragraph
change by

0 Oct 25, 2018 N/A N/A Initial Issue Andrii Gromov

Warnings and Section updated and

1.0 Mar. 30, 2020 N/A Andrii Gromov
Precautions supplemented
Company mailing
address changed
2.0 June 3, 2020 N/A N/A Andrii Gromov
from Miami, FL to
Roselle, IL
The name and
address of the
authorized
3.0 March 16, 2021 N/A N/A Andrii Gromov
representative within
the European Market
changed

3.1 July 12, 2021 Annex D,E N/A New sections added Andrii Gromov

7. NERVE
CANAL
November 29, TRACING;
3.2 N/A New warnings added Andrii Gromov
2021 WARNINGS
AND
PRECAUTIONS
1.1
December 2, 1. Indication for use
3.3 Indications Andrii Gromov
2021 INTRODUCTION added
for Use
WARNINGS
December 2,
3.4 AND N/A New warnings added Andrii Gromov
2021
PRECAUTIONS
WARNINGS
3.5 August 15, 2022 AND N/A New warnings added Andrii Gromov
PRECAUTIONS

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 ImplaStation

MANUFACTURER INFORMATION

PRODIGIDENT INC.
123 Flinn Street,
Batavia, IL 60510,
United States
Phone: +13 (0) 5290-7190
Phone: +380 (67) 787-1100
E-mail: [email protected]
www.implastation.com

AUTHORIZED REPRESENTATIVE in EU

Obelis s.a.
Bd. Général Wahis 53
B-1030 Brussels, Belgium
Phone: 32.2.732.59.54
Fax: 32.2.732.60.03
E-mail: [email protected]

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