TRIOS

GUDID 05902729753746

3shape Trios A/S

Intraoral optical scanning system

• Primary Device ID: 05902729753746
• NIH Device Record Key: e05b511f-9d52-4d28-b7b9-5b9b71165c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIOS
• Version Model Number: TB-04
• 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	05902729753661 [Primary]
GS1	05902729753746 [Package]; Contains: 05902729753661; Package: [3 Units]; In Commercial Distribution

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]

• 05902768365672: Tip used for protection of TRIOS Color and TRIOS Standard Scanners
• 05902768365597: handheld 3D scanner with handle for intraoral scanning.
• 05902768365580: Calibaration kit for TRIOS Color to measure shades
• 05902768365573: Autoclavable scanner tip for TRIOS Color
• 05902768365566: A moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power su
• 05902768365559: TRIOS Pod for handle without scanner
• 05902768365542: handheld 3D scanner with handle for intraoral scanning.
• 05902768365535: Tip used for calibration of TRIOS Color and TRIOS Standard Scanners
• 05902768365528: Autoclavable scanner tip for TRIOS Standard
• 05902729753784: TST-13
• 05902729753777: TSL-01
• 05902729753760: TST-11
• 05902729753685: LP1-2
• 05902729753678: C2BP
• 05902729753746: TB-04