Trios 5 L1P-1F
by 3Shape TRIOS A/S 2 variants
Trios 5 L1P-1F is an intraoral optical scanning system (FDA Class II; FDA product code NBL, Laser, Fluorescence Caries Detection) made by 3Shape TRIOS A/S, cleared under FDA 510(k) K221249 on 16 Sep 2022 and listed in FDA GUDID since 26 Sep 2022 (UDI-DI 05902729753722), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05902729753722 | Date26 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221249 | Date16 Sep 2022 | StatusActive |
Official records
- AccessGUDID record 05902729753722
- FDA 510(k) database K221249
Across registries
- FDA 510(k) K221249 decided 16 Sep 2022 Active
- FDA GUDID UDI-DI 05902729753722 listed 26 Sep 2022 Listed
Timeline
- Cleared FDA 510(k) K221249
- Listed FDA GUDID 05902729753722
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Trios 5
- Generic name
- Intraoral optical scanning system
- Model / reference
- L1P-1F
- Primary DI / UDI-DI
- 05902729753722
- 510(k) Number
- FDA product code
- NBL
- GMDN term
- Intraoral optical scanning system
- Device class
- Class II
- Regulation number
- 872.1745
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Intraoral optical scanning system.