Clearance Summary
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN received FDA 510(k) clearance under submission number K033815, 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 2004-01-15.
- Submission: K033815
- Applicant / Sponsor: Geistlich-Pharma
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2004-01-15
Classification & Regulation
This clearance is catalogued under FDA product code NPM and 21 CFR 872.3930, within the Dental review panel as a Class II device.