PrograScan One+

GUDID 05902729753616

Intraoral scanner w. protection tip

3shape Trios A/S

Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system Intraoral optical scanning system
Primary Device ID05902729753616
NIH Device Record Key3e684005-e4bd-4b98-baba-b91c0fe3c242
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrograScan One+
Version Model NumberS3-2
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
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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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 120 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 80 KiloPascal and 120 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
GS105902729753616 [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 Date2020-12-04
Device Publish Date2020-11-26

On-Brand Devices [PrograScan One+]

05902729753616Intraoral scanner w. protection tip
05902729753593Cord
05902729753586Pod for pen-grip configuration
05902729753579Intraoral optical scanning system, pod with wireless pen grip scanner

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