Clearance Summary
TRIOS Ready Tip received FDA 510(k) clearance under submission number K242103, 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 2025-04-04.
- Submission: K242103
- Applicant / Sponsor: 3Shape TRIOS A/S
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1745
- Decision date: 2025-04-04
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.