Clearance Summary
TSV BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance under submission number K192522, 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 2019-12-09.
- Submission: K192522
- Applicant / Sponsor: Biomet 3i, LLC
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3630
- Decision date: 2019-12-09
Classification & Regulation
This clearance is catalogued under FDA product code NHA and 21 CFR 872.3630, within the Dental review panel as a Class II device.