May 1, 2020

Creating an implant library for the 3Shape

Dental System™

Version 4.0

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Contents
Creating an implant library for the 3Shape Dental System™................................................... 1
1 Introduction..................................................................................................................... 4
2 3Shape´s implant library distribution policy .................................................................... 4
3 Implant library and implant system concept ................................................................... 4
4 The implant library installation workflow........................................................................ 5
Manual import of the implant library ...................................................................... 6
Download over ftp ................................................................................................... 7
5 Preparing CAD files for implant systems.......................................................................... 8
Implant system parts ............................................................................................... 8
5.1.1 One-piece abutments ...................................................................................... 8
5.1.2 Two-piece abutments .................................................................................... 11
3Shape Global Coordinate System for implant systems .......................................... 14
Alignment of implant kit parts ............................................................................... 18
Adjust number of triangles .................................................................................... 21
Preparation of the base file ................................................................................... 23
Preparation of the scan abutment......................................................................... 29
6 Defining an Implant System in the Dental System™...................................................... 32
Importing CAD files and creating abutment kits .................................................... 33
Rotate and translate a group of CAD files ............................................................. 35
Align scan abutment on top surface ...................................................................... 36
3Shape Global Coordinate system and scan abutment swapping ......................... 37
Configuration of manufacturing options ............................................................... 38
Design matrix restrictions for abutments .............................................................. 41
Creating multi-unit abutment kits ......................................................................... 44
Define scan abutment alignment points ............................................................... 47
Settings for implant analog friction bars ............................................................... 49
Implant system categories ..................................................................................... 49
7 3Shape Global Implant Connection ID .............................................................................. 50
8 Implant library encryption ............................................................................................. 53
9 Exporting an implant library .......................................................................................... 55

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10 Creating Implant Libraries for use the United States................................................. 57
11 Dental System™ CAM Output.................................................................................... 58
12 How to design a good scan abutment ....................................................................... 59
13 How to see if a system is digitally signed .................................................................. 60
14 How to see if a library is FDA cleared ........................................................................ 62
15 Example of Implant library ........................................................................................ 63

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1 Introduction

In order to create an implant library for the design of customized abutments, implant bars
and bridges in the Dental System™, 3Shape specific requirements must be met.
This document is a detailed description of the requirements and will guide the implant
library provider through the library creation.

2 3Shape´s implant library distribution policy

3Shape is supporting the creation, distribution and promotion of original and compatible-
with implant libraries under the following requirements:

• The implant library provider is the legal entity providing the Implant library.
• The implant library provider is responsible for obtaining all regulatory clearances
relevant to the library and the parts thereof. Documentation for said clearance
must be supplied to 3Shape where applicable.
• The implant library provider is responsible for the creation, the validation and any
IP violation in relation to the library
• 3Shape only supports the distribution of the library to end customers if the
providers has signed the implant library contract with 3Shape and the library has
been provided to 3Shape
• The 3Shape reseller must approve the distribution of the implant library to his end-
customers

3 Implant library and implant system concept

Implant Systems in the Dental System Control Panel are organized as following:

• An implant library is a digital representation of one or more implant systems.

• An implant system typically corresponds to a given implant type. In addition a
number of implant systems can be grouped in a category, see sect. 5.5.
• Each implant system contains a number of parts – implants, scan abutments,
screws, bases, interfaces, analog interfaces, etc. See sect. 4.1 for details.
• An abutment kit typically corresponds to a specific implant connection/diameter
of the implant type. An abutment kit is an assembly of parts needed to complete
the design of the customized abutment. Abutment kits are created by referencing
the models added to a given implant system. Multiple abutment kits can reference
the same parts and these kits, hence, allow you to easily combine the various parts
belonging to a given implant system.

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The diagram below illustrates the example of an implant system and one of its abutment
kits:

Figure 3-1: Implant system structure in the Dental System™.

4 The implant library installation workflow

Below figure illustrates the workflow for the installation of the implant libraries by the
dental laboratory and the creation and provision of the implant library by the implant
library provider.

The Implant library

provider creates or
updates the implant
library using 3Shape
Dental System

The Implant library

3Shape provides 3Shape server with
provider uploads
the 3Shape Dental the implant library whitelist of FDA
System to ftp approved libraries

The 3Shape
The dental lab The dental lab
Abutment Designer
The dental lab retrieves and installs designs within the
contacts the 3Shape The design is sent
installs the 3Shape the implant library limitations of the
server to obtain for manufacturing
Dental System from the implant settings in the
clearance to use the
library provider implant library
library

Figure 4-1: Workflow for the installation of implant libraries

Please see section 6 for a description how to create and update the implant library.

The dental lab has two ways to retrieve the implant library from the implant library
provider:

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1. Manual import of the implant library
2. Download over ftp

Manual import of the implant library

In the Control Panel the under Tools –> Import / export it is possible to import the implant
library by selecting “Import materials”.

Figure 4-1: Implant library import in the Dental System™.

After locating and selecting the implant library file a dialogue shows the contents i.e. the
implant systems that the implant library file contains. The appropriate implant systems are
then selected for import.

Figure 4-2: Import and update materials.

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Download over ftp

In the Control Panel the under Tools –> Download center it is possible to retrieve materials
from ftp either by selecting the Download materials or the Download libraries option.

Figure 4-3: Materials download.

Figure 4-4: Implant library download.

In the Download libraries option it is possible to select which library should be retrieved
and installed. Please see section 14 on how to identify if a library is cleared for use in the
US by FDA.

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5 Preparing CAD files for implant systems

This section details the requirements for the CAD files used for customized abutment
design.

For the preparation of CAD files for implant libraries in the Dental System™ it is
recommended to use the 3Shape ShapeDesigner (Version 1.1.16.0).
The following screenshots are captured in the ShapeDesigner software and illustrate how
to work with the ShapeDesigner when preparing the CAD files.

It is recommended for exporting and encrypting the implant libraries, that all files are
being saved in:

C:\...\3Shape Configuration\DentalSystem\Dental System Control Panel\library\3Shape\

Abutments\ImplantSystems\ImportedSystems

All CAD files used for abutment design must be saved in either stl or dcm format,
measurement unit should be set to mm.

Implant system parts

The 3Shape Dental System™ distinguishes between CAD files for one-piece and two-piece
abutments. Below the different implant system parts and their respective requirements for
the CAD files are described.

5.1.1 One-piece abutments

Implant

There are no specific requirements for the model of the implant. This
model is used for visualization purposes only.

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Scan abutment

The model corresponds to the physical scan abutment.

However, the non-visible part of the model -such as the inside of the
screw hole and the interface- should be deleted to maximize alignment
accuracy.

The design of the scan abutment is important for achieving an accurate

fit, which is particular important for implant bridges.

Screw

There are no specific requirements for the model of the screw.

The model of the screw is used to automatically generate a correctly
shaped hole through the abutment.

In case of using a pre-milled blank with pre-defined screw hole, the

generated screw hole can be automatically removed from the CAM
output (see sect. 3.2).

Abutment connector base

The model of the abutment connector base is a very crucial model in the
abutment kit. This surface describes the shape of the abutment part,
which “connects” either directly to the implant or to the interface. The
model is also the base or seating surface of the customized abutment.

The following requirements exist for the base geometry:

1. The model must contain EXACTLY one boundary. Hence, this is

not a watertight model nor should it contain the hole for the
screw. This will be automatically generated.
2. The normals of this surface must point outwards. The image to
the left, hence, shows the BACKSIDE of the base surface as the
interface goes "into" the abutment.
3. If needed, this surface should be DRILL COMPENSATED – i.e.
contain no sharp edges which cannot be milled

Note: For regulatory reasons, the 3Shape software will refuse to output
the connector base if the end user is located in the United States.

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Blank

The blank model should be a cylinder without screw hole and interface.
This model is used to visualize the size of the blank.

Digital model analog interface (optional)

Digital model analog interface is used for creating a

hole, where model analog is inserted.
The model should contain either

• two boundaries (model analog interface with

the bottom insertion)

OR

• one boundary at the top of the model (model

analog interface with insertion from the top)

Inner limit (optional)

The inner limit model should be a cylinder without

screw hole. This model is used to visualize the
limitations for the minimum geometry of the
abutment.

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5.1.2 Two-piece abutments

Implant

There are no specific requirements for the model of the implant. This model
is used for visualization purposes only.

Scan abutment

The model corresponds to the physical scan abutment.

However, the non-visible part of the model -such as the inside of the screw
hole and the interface - should be deleted to maximize alignment accuracy.

The design of the scan abutment is important for achieving an accurate fit,
which is particular important for implant bridges.

Screw

There are no specific requirements for the model of the screw.

The model of the screw is used to automatically generate a correctly shaped
hole through the abutment.

In case of using a pre-milled blank with pre-defined screw hole, the

generated screw hole can be automatically removed from the CAM output
(see sect. 3.2).

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Abutment connector base

The model of the abutment connector base is a very crucial model in the
abutment kit. This surface describes the shape of the abutment part, which
“connects” either directly to the implant or to the interface pin. The model
is also the base or seating surface of the customized abutment.

The following requirements exist for the base geometry:

1. The model must contain EXACTLY one boundary (*). Hence, this is
not a watertight model nor should it contain the hole for the screw.
This will be automatically generated.
2. The normals of this surface must point outwards. The image to the
left, hence, shows the BACKSIDE of the base surface as the interface
goes "into" the abutment.
3. If needed, this surface should be DRILL COMPENSATED – i.e. contain
no sharp edges which cannot be milled.

Note: For regulatory reasons, only implant systems cleared by the FDA are
enabled in the software for end-users located in the United States.

Abutment interface

There are no specific requirements for the model of the interface.

This file is for visualization only, the 3Shape software does not allow any
changes by the end-user to this file during the abutment design process.

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Blank (optional)

The blank model should be a cylinder without screw hole and interface. This
model is used to visualize the size of the blank.

Digital model analog interface (optional)

Digital model analog interface is used for creating a hole,

model analog is inserted.
The model should contain either

• two boundaries (model analog interface with

the bottom insertion)

OR

• one boundary at the top of the model (model

analog interface with insertion from the top)

Inner limit (optional)

The inner limit model should be a cylinder without a

screw hole. This model is used to visualize the
limitations for the minimum geometry of the abutment.

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3Shape Global Coordinate System for implant systems

Implant libraries have to be created according to 3Shape´s Global Coordinate System to

ensure compatibility of implant libraries in the Dental System™ and compatibility between
3Shape Dental System, Implant Studio and TRIOS applications.

Positioning the implant in conformity with the requirements is important for Dental
System™ and Implant Studio™ libraries compatibility in order to obtain correct abutment
placement.

TIP: If you need to rotate and translate many files with the same transformation, it is
possible to use the new transformation functionality, see section 6.2.

To be in compliance with the 3Shape Global Coordinate System the following is required:

1. The implant shoulder has to be in the X-Z plane both for internal and external hex.

External connection Internal connection

Figure 5-1: Alignment of the Implant shoulder in the X-Z plane

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Tapered connection

Figure 5-2: Alignment of the implant shoulder to the X-Z plane

2. The corner of the seating geometry has to be aligned with the Z-axis e.g. the corner of
the triangle, hexagon, pentagon or octagon

X
X

Z
Z

Alignment of triangle to Z-axis Alignment of hexagon to Z-axis

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X X

Z Z

Alignment of pentagon to Z-axis Alignment of octagon to Z-axis

Figure 5-3: Alignment of the seating geometry to the Z-axis

Furthermore, the Y-axis of the coordinate system should be aligned with the vertical axis
and point upwards – i.e. away from the implant.

The model parts (described in sect. 4.1) must be precisely aligned to each other and
exported in one common coordinate system. When handled in this coordinate system, the
set of models should form a complete assembly – i.e. be positioned relative to each other
as would be the case when assembled into a complete implant.

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1. Base
2. Interface
3. Implant
4. Screw

Figure 5-4: CAD models of an abutment kit exported in a common coordinate system

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Alignment of implant kit parts

Transform all items in the same coordinate system and align all parts properly…

Figure 5-5: Alignment of all items into the same coordinate system

• All faces should be aligned that occlusal surfaces face y-axis

• The y-axis is the symmetric rotation axis of the implant
• The origin (x-z plane) is equal to the implant shoulder

TIP: If you need to rotate and translate many files with the same transformation, it is
possible to use the new transformation functionality, see section 0.

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Check the fit with the 2D-cross section in horizontal…

…and vertical plane

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Use the transformation function to adjust the objects…

Make sure the parts are perfectly

aligned – this has major influence on the
precision of the designed restoration.

Note that identical looking surfaces may

lead to self- intersections caused by a
numerical issue in the software. To
avoid this issue move up the surface on
top about 0,001mm.

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Adjust number of triangles

The recommended maximum values for the CAD files of the different implant kit parts are:

• Implant max. 25000

• Scan abutment max. 35000
• Screw max. 15000
• Base max. 25000
• Interface max. 15000
• Blank max. 15000
• Inner limit max. 15000

All parts of the implant kit must to be checked like shown below. Too many triangles will
slow down the system.

Right click the item in order to detect the number of used triangles.

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Make sure to keep the value within the maximum range. 3Shape recommends for the
screw e.g. a max number of 15000 triangles. If needed, decimate the number of triangles.

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Preparation of the base file

Mark unused surfaces…

Delete the marked surfaces…

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Close open surfaces…

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Make sure, the surface normals are facing to the negative Y-direction. If not,
use “swap normals” to fix the file…

The normals’s surface can be recognized as this surface is still visible even when the “show
backface” option is turned off.

Show backface of 3D item

Show shadows of object

Show mesh of 3D item

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Inspect the mesh of the base file. This is a very critical aspect. Long and thin triangles
should be avoided.

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Close holes in base’s surface…

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Repair mesh…

Make sure the item has only one

boundary. In case it has still more than
one boundary, repeat the previous step
“Close holes”.

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Preparation of the scan abutment

The non-visible part of the model, such as the inside of the screw hole, and the non-
necessary surfaces must to be deleted.

Mark unused surfaces….

Delete the marked surfaces….

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Optimize mesh….

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6 Defining an Implant System in the Dental System™

Creating implant systems is easily done using the Dental System™ Control Panel. How to
configure abutment kits for the customized abutment design is described step by step in
the following section.

Please note, that implant libraries are forward compatible.

If you create a library, using Dental System 2014 version, it won’t be possible to use it in
older version of the software – Dental System 2013, while Dental System 2014 and newer
would be able to import it.

We are constantly adding new features, such as 3Shape Global Coordinate System for
implant systems (see chapter 4.2), and 3Shape Global Implant Connection ID (see chapter
6), so it’s important to use the latest version in order to use new functions.
However, older version would provide implant library with wider compatibility over
different versions.

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Importing CAD files and creating abutment kits

Open the Dental System™ Control Panel and go to Abutments > Implant Systems. This will
bring up the Details mode of the implant systems:

Figure 6-1: Defining implant systems and abutment kits in the Control Panel

1. To add a new implant system, press the Add button under Implant System - (1) -
and enter a unique ID, the name for the new system and a version number.
2. To add parts/CAD files to the selected implant system, press Add under the
implant system parts - (3) - and browse the file. Import all the desired parts before
proceeding to the next step.

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3. To create abutment kits from the parts of the active implant system, click the Add
button under Abutment kits - (2). This will bring up a wizard which will guide you
through the part selection.

A Table mode for the implant systems has been implemented for a better overview and an
easier and faster editing of abutment kits. A double-click activates the fields and values can
be changed.

Figure 6-2: Table mode for implant systems

Browsing CAD files and creating abutment kits have still to be done in the details mode as
shown and described above.

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Rotate and translate a group of CAD files

New feature “Transform”, allows rotating and repositioning of entire set of models with
the same transformation saving time and reducing the number of errors.

Select folder with models, and click “Apply”. Files would be updated in the same folder.

Figure 6-3: Transformation of entire sets of models using the “Transform” feature

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Align scan abutment on top surface

The alignment algorithm has been improved in order to achieve better results mainly for
the alignment of scan abutments with a horizontal top surface. This improvement ensures
a better vertical locking of the implant position as well as the locking of the scan abutment
rotation.

Implant system providers can enable the option Align with top surface when browsing
their scan abutment CAD file (see sect. 5.1 step 2).

Figure 6-4: Align with top surface option

To read more about the requirements of scan abutments in order to achieve optimized
scan results, please refer to sect. 10.

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3Shape Global Coordinate system and scan abutment swapping

The first page of this abutment kit configuration wizard (described in 5.1 part 3) contains
the option 3Shape Global Coordinate system. By enabling the option, the implant library
can be used with 3rd party scan abutments and the scan abutment of the created library
can be used with 3rd party implant libraries. In addition, it is mandatory for integration with
Implant Studio and TRIOS.

In order to ensure the multi-compatibility of scan abutments the implant libraries have to
be created in conformity with the requirements of the 3Shape Global Coordinate System
described in sect. 4.2.

Figure 6-5: Swap scan abutment option

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It is now also possible to check multiple scan abutments for one kit. By checking two or
more scan abutments for the Kit you allow user to swap scan abutments during design.

Figure 6-6: Multiple Scan Abutments selection

Configuration of manufacturing options

The abutment manufacturing options allow the user to specify how abutments designed
using the abutment kit in question should be exported.

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Figure 6-7: Manufacturing options

Use implant coordinates - when checked, the final abutment geometry is stored in the
common coordinate system of the implant system parts. Furthermore, it allows rotating
the output around the z-axis, if required for the production.
If this option is not checked, the final implant will be stored in the coordinate system of the
preparation scan used for designing the abutment.

Keep base - when unchecked, the base geometry is removed from the exported model and
replaced with a planar surface.

Note: For regulatory reasons, the 3Shape software will refuse to output the connector
base if the end user is located in the United States.

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This allows the use of milling blanks with the pre-milled base geometry.
The base geometry will be removed for one-piece abutments and kept for two-piece
abutments.

Base geometry removed Base geometry included

Append hole patches - when checked, the screw hole of the abutment is closed in the
exported geometry. This allows the use of milling blanks with the pre-drilled screw holes.

Screw hole closed Screw hole appended

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Design matrix restrictions for abutments

In the end of the wizard design limitations for the abutments designed using the abutment
kit in question can be defined. There are default values for each parameter, which can be
overwritten for every individual abutment kit by the implant provider during the creation
of the implant library.

Figure 6-8: Design matrix in the wizard for abutments

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Figure 6-9: Design matrix in the wizard for Implant Bars and Bridges

Limit maximum top cap angle: The abutment top cap is checked to comply with the
specified maximum angle value. This check is always performed and cannot be disabled.

Perform validation - If the option is selected, the user won´t be able to design abutments
which violate the following design matrix specifications.

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Abutments

Figure 6-10: Design matrix measurements for Abutments

Table 1: Design parameters annotated in Figure 6-10

FIGURE 6- PARAMETER PART CONSTRAINT
10 REF.
A Collar Height Titanium base Not modifiable

B Ti-Base Diameter Titanium base Not modifiable

C Gingival Margin Diameter Customized abutment Minimum/Maximum limit

D Gingival Margin Height Customized abutment Minimum/Maximum limit

E Total Height Customized abutment Minimum/Maximum limit

F Angulation Customized abutment Maximum limit

G Top Cap Height Customized abutment Minimum/Maximum limit

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Screw Retained Crowns

Figure 6-11: Design matrix measurements for Screw Retained Crowns

Table 2: Design parameters annotated in Figure 6-11

FIGURE 6- PARAMETER PART CONSTRAINT
11 REF.
A Collar Height Titamium base Not modifiable

B Ti-Base Diameter Titanium base Not modifiable

C Gingival Margin Diameter Crown/Superstructure Minimum/Maximum limit

D Total Height Crown/Superstructure Minimum/Maximum limit

Perform blank validation – If the option is selected, the user won´t be capable to violate the
design constraints given by the blank file.

Block user from continuing on inner limit violation – If the option is selected, the user won´t
be capable to violate the design constraints given by the inner limit file.

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Allow angled screw hole – If the option is selected, the user is allowed to angulate the screw
hole within the limitations set by the implant kit provider.

Angled screw hole starting point – Defines from where the screw hole angulation will be
applied in the abutment design.

Number of possible base rotation angles – Allows the user to rotate the abutment
connector base within the limitations set by the implant kit provider.

Individual thickness around hole – If the option is selected, the user won’t be able to
design abutments with the individual thickness around screw hole less than the value
entered.

Implant Bar Validation – If the option is selected, the user won’t be able to design implant
bars which violate the following specifications: Maximum Anterior-Posterior spread,
Minimum connection area and Maximum implant span.

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Creating multi-unit abutment kits

The MUA piece is defined as an interface with the two additional parameters depicted
below:

Figure 6-12: (1) Angle from implant direction; (2) Offset from implant position

To create implant kits with multi-unit abutments one can set the parameters at the end of
the wizard:

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Figure 6-12: Wizard for Multi-Unit Abutments

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For most abutments the abutment interface direction is the same as the implant direction.
The exception to this are Multi-unit abutments, where an angled interface makes the
interface direction differ from the implant direction. In this case it is important to note that
the top cap angle is measured from the interface direction as seen in the figure below.

(1) Top cap angle

(2) Abutment top cap insertion
direction
(3) Abutment interface direction
(4) Implant direction
(5) Abutment top cap
(6) Abutment interface
(7) Implant

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Define scan abutment alignment points

Implant system providers can now pre- define alignment points to ensure an optimal
alignment of the scan abutment during the scanning process.

The alignment points can be set under Preview (1) in the Abutment Kit box. In the preview
window, 1-point or 3-point alignment (2) can be selected. By clicking on Set point or Set
points, the alignment points can be pre-defined on the scan abutment.

Figure 6-13: Set alignment points

The following should be taken into account when pre-defining the scan abutment
alignment points:

- The alignment points can be set on any sufficient and visible surface – the
placement in deep indentations as e.g. screw channels are to be avoided
- The alignment points should not be placed close to or on any edge
- The placement of the points should be considered as an easy-to-match position for
the user

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Figure 6-14: Recommended alignment point setting

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Settings for implant analog friction bars

When importing a model analog for the production of implant models additional
parameters can be defined as shown below.

Figure 6-15

Friction surface top - The distance from Y= 0 mm to the top of the friction bar. If for
instance you want the friction bar to have its top point in Y= -1 mm, set the parameter to
1.1 mm.

Friction surface bottom - The distance from Y= 0 mm to the bottom of the friction bar. If
for instance you want the friction bar to have its bottom point in Y= -6 mm, set the
parameter to 6.0 mm.

Implant system categories

Implant systems can be organized into categories for an easier selection in the Dental
Manager Order form.

1. Click the Add button in the Implant system categories window.

2. Enter a name for your category in the appeared form.
3. Click OK.
4. Click the Add current system button to include the implant system you are
currently working with into the selected category.
5. Every implant system page contains Implant system categories, so you can click on
your category and add that implant system to the list.

Figure 6-16

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7 3Shape Global Implant Connection ID

In order to ensure the automatic mapping of implant selections between the 3Shape
applications Dental System™, TRIOS® and Implant Studio™, a Global Implant Connection ID
has to be defined for each original implant brand.

Implant system providers are responsible for generating Global Implant Connection IDs
when creating the implant library in the Dental System™ Control Panel.

By providing the requested information as described below, the Global Implant Connection
ID will be automatically generated according to the naming convention of the 3Shape
Global ID:

Manufacturer_System_Connection

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Figure 6-15: Creation of Global Implant Connection ID in the Control Panel

The following information has to be provided by the implant system provider:

(1) Original Manufacturer: Select one of the listed implant manufacturers (e.g. Nobel
Biocare, Straumann, Phibo or Avinent)

(2) System: Insert the implant brand (e.g. NobelActive, SLA, TSA Advance or Coral HI)

(3) Connection: Type the name or dimension of the interface or platform on the implant
shoulder level (e.g. NP, RN, S4 or 4.1)

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Example of Global Implant Connection IDs:

Manufacturer System Connection Global Implant Connection ID

Straumann Soft Tissue Level RN Straumann_Soft Tissue Level_RN
Straumann Soft Tissue Level WN Straumann_Soft Tissue Level_WN
Straumann Soft Tissue Level NNC Straumann_Soft Tissue Level_NNC
Straumann Bone Level RC Straumann_Bone Level_RC
Straumann Bone Level NC Straumann_Bone Level_NC
Nobel Biocare Replace NP Nobel Biocare_Replace_NP
Nobel Biocare Replace RP Nobel Biocare_Replace_RP
Nobel Biocare Replace WP Nobel Biocare_Replace_WP
Nobel Biocare Replace 6.0 Nobel Biocare_Replace_6.0
Nobel Biocare Branemark NP Nobel Biocare_Branemark_NP
Nobel Biocare Branemark RP Nobel Biocare_Branemark_RP
Nobel Biocare Branemark WP Nobel Biocare_Branemark_WP
Nobel Biocare Conical Connection NP Nobel Biocare_Conical Connection_NP
Nobel Biocare Conical Connection RP Nobel Biocare_Conical Connection_RP
Nobel Biocare Conical Connection 30 Nobel Biocare_Conical Connection_3.0
BEGO S-Line 5.5 BEGO_S-Line_5.5
Biodenta BL B0 Biodenta_BL_B0
CAMLOG iSy 3.8 CAMLOG_iSy_3.8
Phibo TSA/ADV S5 Phibo_TSA/ADV_S5
Euroteknika Naturactis NP Euroteknika_Naturactis_NP

Important: In order to ensure the compatibility of implant libraries with the 3Shape
applications Dental System™, TRIOS® and Implant Studio™, the implant libraries must be
created in conformity with the requirements of the 3Shape Global Coordinate System
described in sect. 4.2.

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8 Implant library encryption

Encrypting the created implant libraries used for customized abutments and bars is
essential to protect the intellectual properties and avoid copying. Not just the libraries can
be encrypted but also the manufacturing output. 3Shape strongly recommends partners to
encrypt their libraries.

Note: For regulatory reasons, only implant systems cleared by the FDA are enabled in the
software for end-users located in the United States. Since this is achieved by means of
encryption, all Implant Libraries in this region must be encrypted and documentation for
clearance must be provided to 3Shape before the library can be used.

The libraries can be encrypted in the following 6 ways.

Open CAD Output Encrypted CAD output

Protection / CAD (typically central
(typical local
Output manufacturing)
manufacturing )
Dongle protected (local
Option A Option B
dongle enabling)

Available to all 3Shape

users (no dongle Option C Option D
enabling)

Available to selected
3Shape reseller (local Option E Option F
dongle enabling)

The horizontal options refer to library protection options whereas the vertical options refer
to the CAD output used for manufacturing

Dongle protected
This option means that the library needs to be enabled on each individual dongle. The
option is very good if the library needs to be added to the resellers own dongles, but if the
used scanners has been sold by a third party 3Shape reseller then this third party reseller
need to approved the enabling, which can be cumbersome and slow. The actual enabling
needs to be performed by 3Shape.

Available to all 3Shape users

This option basically means that all 3Shape users can install and design using the library.

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Available to selected 3Shape reseller
The last option enables selected resellers to enable the library on the scanners sold by this
reseller using the site connection administration tool. Each resellers can be enabled by
request to 3Shape.

Open CAD Output

This option refers to the CAD output used for manufacturing. This option means that the
CAD output can be outputted locally and used on any milling machine. This output is
typically used for when pre-manufactured CAD/CAM abutment are used.

Encrypted CAD output

This option refers to the CAD output used for manufacturing. This option means that the
CAD output can only be decrypted by library owner selected sites – typically the central
manufacturing site. This option requires a 3Shape DentalManager Inbox to decrypt the
output for manufacturing. This output is often used for central manufacturing.

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9 Exporting an implant library

The export functionality in Dental System™ Control Panel provides an easy exchange of
materials. Go to Tools > Export/Import button and click on “Export materials”

Select the desired materials from the list. Before exporting the implant library the
following options can be selected:

Lock exported materials- when this option is checked, the material settings cannot be
changed at the receiving end (recommended).

FDA cleared libraries are locked: All implant libraries that have been cleared for use in the
US are automatically locked so that the end user is not able to change the implant library
settings.

Always overwrite materials with the same IDs when importing- when this option is
checked, materials with the same ID will automatically be replaced at the receiving end.

Delete pre-existing items in destination materials- when this option is checked, all existing
materials at the receiving end will be deleted when importing new materials.

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Click on the “Export to File” button to export the implant library in .dme format.

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10 Creating Implant Libraries for use the United States

If the end-user is located in the United States, only FDA-cleared abutment

components/libraries are available for use in 3Shape Dental System™.

This is due to a request from the FDA and thus only applies for installations in the United
States.

In order to make a library available in Dental System™ the Implant Library Provider is
required to send documentation to 3Shape in form of an electronic copy of the relevant
510(k) clearance letters.

The Implant Library Provider also needs to sign and forward a confirmation letter stating
that the library only consists of FDA-cleared components to the extent that clearance is
required for said component.

Please be aware that the Implant Library Provider is responsible for ensuring that the
library only contains FDA-cleared components to the extent that clearance is required for
said component.

Implant Libraries for use in the United States will only function in the 3Shape Dental
System™ if they are encrypted and locked, and have been approved by 3Shape.

Please contact [email protected] for more information.

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11 Dental System™ CAM Output

The CAM output is generated according to the standard specification for CAD/CAM output.
CAD files are exported in STL format and the final abutment geometry is oriented in the
coordinate system aligned to the Z-axis.

Figure 10-16: CAM output coordinate system

The implant position and orientation is defined relative to the position of the implant in
the implant library used in the 3Shape software. The output file is an XML file and it
contains a list of the included implants. To learn more about the implant position output
format for abutments, implant bars and bridges created in the 3Shape Dental System™
please contact [email protected] for more information.
The abutment output can be further specified for every individual abutment kit. As
described in section 3.2, it can be defined whether the manufacturing output should have
a specified rotation around Z-axis, if it contains the screw hole and/or includes the base
geometry (base geometry output not possible for end-users located in the United States).

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12 How to design a good scan abutment

When designing a scan abutment it is very important to understand how the scanners
work. Basically the scan abutment is scanned and the scanned surface is matched to the
CAD of the scan abutment minimizing the difference between the 2 surfaces. During this
matching it is critical that the scanned surface has sufficient surfaces to lock all positions
and orientations.

Dental System™ 2012 - Model Builder™ (min. 2.14)

http://www.youtube.com/watch?v=kQ8DA6wD9aM&list=UUxEI9LrUl3A7SjkOPbDLPpg&index=3&feature=plcp

The following should take in account when designing a scan abutment for the 3Shape
Dental System™:

• Sufficient horizontal surface for vertical locking of the implant position

• Conical scan abutment are to be avoid in order to achieve better results in the
vertical alignment
• A non-symmetric feature, preferred a limited vertical flat surface or sufficient
bevel surface to lock the rotation of the scan abutment
• Avoid sharp edges to ensure an accurate alignment of the scan abutment and the
CAD file of the scan abutment
• Scanable material, e.g. Peek, which has sufficient scan properties, but notice that
there are different types of peek with varying scan quality
• Make sure to use intraoral approved material to ensure the usability for intraoral
and lab scanner

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13 How to see if a system is digitally signed

Digital signature is essential for protection of intellectual rights and for FDA clearance
mechanism.
Please ensure, that your implant library models are digitally signed with following steps:

1. Open Dental System Control Panel, and navigate to Abutments -> Implant
Systems. Select your implant system.
2. Choose model file – implant model, for example, and scroll down to details.
3. Check “Digital signature” value.

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This is an example of a file that is NOT signed

Digitally signed. The signature used is “3ShapeImplantSystem”

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14 How to see if a library is FDA cleared

1. Open Dental System Control Panel, and navigate to Abutments -> Implant
Systems. Select your implant system.
2. Choose abutment kit and scroll down to details.
3. Check FDA logo presence.

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Please note that the library in the figures above is the 3Shape internal test and demo
library which cannot be used for production.

15 Example of Implant library

This section provides an example of an Implant library setting; the standard 3Shape
Implant 4.3mm library which is provided with the software.

The library contains two abutment kits:

• 1 pcs Abutment 4.3 mm

• 2 pcs Abutment 4.3 mm

By selecting on of the kits the contents of the implant kit is shown. Below illustrates the 1
pcs Abutment 4.3 mm implant kit content and preview of the 3d models:

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FDA

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Below shows the settings for the 3Shape 1 pcs Abutment 4.3 mm implant kit. For details on
the specific settings and how to maintain these please see section 6.

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