TRIOS Core

GUDID 05902729753883

Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner

3shape Trios A/S

Dental milling system, CAD/CAM, chairside
Primary Device ID05902729753883
NIH Device Record Key3b5af618-9e22-4dea-94bf-8ff0088483e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIOS Core
Version Model NumberS1P-4
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
Phone+4570272620
Emailsupport@3shape.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 110 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105902729753883 [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 Date2024-05-27
Device Publish Date2024-05-17

On-Brand Devices [TRIOS Core]

05902729753883Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner
05902729753876Color pen-grip intraoral scanner w. protection tip

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