TRIOS 3

GUDID 05902729753852

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

3shape Trios A/S

Dental milling system, CAD/CAM, chairside

• Primary Device ID: 05902729753852
• NIH Device Record Key: 174df5ae-dc76-4329-abf2-709726ba08b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIOS 3
• Version Model Number: S1P-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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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 110 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 110 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	05902729753852 [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: 2024-05-27
• Device Publish Date: 2024-05-17

On-Brand Devices [TRIOS 3]

• 05902768365474: handheld 3D scanner with pen grip for intraoral scanning.
• 05902768365450: Enables TRIOS® 3 systems to measure shades.
• 05902768365443: Tip used for calibration of the TRIOS® 3 Scanner.
• 05902768365436: Tip used for protection of the TRIOS® 3 Scanners.
• 05902729753890: Pod for Pen-grip configuration
• 05902729753869: Color pen-grip intraoral scanner w. protection tip
• 05902729753852: Intraoral digital impression system for CAD/CAM Pod with pen-grip scanner