TRIOS

Basic Information

• Brand Name: TRIOS
• Primary DI: 05902729753661
• Version / Model: TB-04
• Company Name: 3shape Trios A/S
• Labeler DUNS: 305225025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-26
• Public Version: 1
• Public Version Date: 2022-10-04
• Public Version Status: New
• Public Device Record Key: e05b511f-9d52-4d28-b7b9-5b9b71165c68

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBL	Laser, Fluorescence Caries Detection	Dental	872.1745	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63669	Intraoral optical scanning system	An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05902729753746	GS1		3	In Commercial Distribution
Primary	05902729753661	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221249	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 80 – 110 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 122 Degrees Fahrenheit