Trios Move+

GUDID 05902729753838

3shape Trios A/S

Intraoral optical scanning system
Primary Device ID05902729753838
NIH Device Record Keyf035f637-d6c8-4459-947f-6ca4fee8468f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrios Move+
Version Model NumberC4.1
Company DUNS305225025
Company Name3shape Trios A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 78.8 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105902729753838 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-14
Device Publish Date2023-09-06

Devices Manufactured by 3shape Trios A/S

05902729754057 - TRIOS Patient Monitoring2024-11-07 The TRIOS Patient Monitoring software can be used for the visualization and comparison of 3D scans of the dentition.
05902729753852 - TRIOS 32024-05-27 Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner
05902729753869 - TRIOS 32024-05-27 Color pen-grip intraoral scanner w. protection tip
05902729753876 - TRIOS Core2024-05-27 Color pen-grip intraoral scanner w. protection tip
05902729753883 - TRIOS Core2024-05-27 Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner
05902729753890 - TRIOS 32024-05-27 Pod for Pen-grip configuration
05902729753838 - Trios Move+2023-09-14
05902729753838 - Trios Move+2023-09-14
05902729753791 - 3Shape F82023-04-04 The 3Shape F8 is used to record the topographical characteristics of the dentition by scanning objects, for example teeth, denta

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