TRIOS 5

GUDID 05902729753722

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

• Primary Device ID: 05902729753722
• NIH Device Record Key: 150bb8a7-6e6c-415b-a20b-d69af4d993b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIOS 5
• Version Model Number: L1P-1F
• Company DUNS: 305225025
• Company Name: 3shape Trios A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 14 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05902729753722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221249

FDA Product Code

• NBL: Laser, Fluorescence Caries Detection

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: 2022-10-04
• Device Publish Date: 2022-09-26

On-Brand Devices [TRIOS 5]

• 05902729753739: L1-2
• 05902729753722: L1P-1F