PrograScan One+

GUDID 05902729753586

Pod for pen-grip configuration

3shape Trios A/S

Intraoral optical scanning system

• Primary Device ID: 05902729753586
• NIH Device Record Key: e80d2a35-65f9-4a10-bb5e-f9f7272aa258
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PrograScan One+
• Version Model Number: PS3-2
• Company DUNS: 305225025
• Company Name: 3shape Trios A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com
• Phone: +4570272620
• Email: support@3shape.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 120 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902729753586 [Primary]

FDA Product Code

• NOF: System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-11-26

On-Brand Devices [PrograScan One+]

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