DEVICE: 3Shape (05902768365030)
Device Identifier (DI) Information
3Shape
D810
Not in Commercial Distribution
3shape A/S
D810
Not in Commercial Distribution
3shape A/S
The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental models and impressions – for use with CAD/CAM dental restoration design.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34713 | Dental milling system, CAD/CAM, laboratory |
An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations and/or orthodontic appliances (archwires) produced in the dental laboratory. It typically includes three-dimensional (3-D) image acquisition capabilities that provide values (measurements) from, e.g., casts, models or chairside in vivo acquisition to acquire the prescription values for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for production of the actual device(s) for delivery and final fitting to the patient.
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FDA Product Code
[?]Product Code | Product Code Name |
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NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 7000 and 11000 KiloPascal |
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 15 and 35 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 7000 and 11000 KiloPascal |
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1ed199c2-06ae-4455-a097-eed2e8d82601
April 04, 2023
4
September 21, 2016
April 04, 2023
4
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4570272620
support@3shape.com
support@3shape.com