Clearance Summary
BIO-OSS ANORGANIC BOVINE BONE received FDA 510(k) clearance under submission number K970321, sponsored by Geistlich-Pharma. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-09-15.
- Submission: K970321
- Applicant / Sponsor: Geistlich-Pharma
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 1998-09-15
Classification & Regulation
This clearance is catalogued under FDA product code LYC and 21 CFR 872.3930, within the Dental review panel as a Class II device.