DEVICE: 3Shape Dental System (05902768365092)

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Device Identifier (DI) Information

3Shape Dental System
2016-1

3shape A/S
05902768365092
GS1
1
The 3Shape Dental System™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching dental restorative prosthetics using computer aided design. The output of the device is a computer file containing the restoration(s) in digital form which can be used by 3rd party providers of milling machines and/or rapid prototyping machines to manufacture physical prosthetics. The 3Shape Dental System™ Software does not provide any means of creating physical restorations. Both “Crown and Bridge” and Customized Abutments are supported by the device as well as a number of other prosthetic types. The 3Shape Dental System™ Software can be run on properly configured “off-the-shelf” PC hardware running Microsoft® Windows and using a standard keyboard and mouse.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
CAD/CAM software A software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).
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FDA Product Code

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Product Code Product Code Name
NOF System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 25, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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+4570272620
support@3shape.com
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