DEVICE: TRIOS 3 (05902768365450)

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Device Identifier (DI) Information

TRIOS 3
TRIOS 3 Color Calibration Kit

3shape Trios A/S
05902768365450
GS1
1
Enables TRIOS® 3 systems to measure shades.
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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
Dental CAD/CAM system, chairside An assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient.
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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
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
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

Not in Commercial Distribution
September 22, 2016
August 24, 2017
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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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+4570272620
support@3shape.com
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