TRIOS

GUDID 05902729753760

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: 05902729753760
• NIH Device Record Key: 5ff2e5e2-53ca-40fb-9fcc-8fbb25602fa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIOS
• Version Model Number: TST-11
• 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

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	05902729753753 [Primary]
GS1	05902729753760 [Package]; Contains: 05902729753753; 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: true
• Device Is Sterile: false

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

[05902729753760]

Moist Heat or Steam Sterilization

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