Clearance Summary
L1P-1F (TRIOS 5) received FDA 510(k) clearance under submission number K221249, sponsored by 3Shape TRIOS A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-09-16.
- Submission: K221249
- Applicant / Sponsor: 3Shape TRIOS A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2022-09-16
Classification & Regulation
This clearance is catalogued under FDA product code NBL and 21 CFR 872.1745, within the Dental review panel as a Class II device.