Clearance Summary
TSX Implants received FDA 510(k) clearance under submission number K220978, sponsored by Biomet 3i, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-09-14.
- Submission: K220978
- Applicant / Sponsor: Biomet 3i, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 2022-09-14
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.