Clearance Summary
OTA COLLAGEN BIOMATERIAL received FDA 510(k) clearance under submission number K073685, sponsored by Osseous Technologies of America. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-08-29.
- Submission: K073685
- Applicant / Sponsor: Osseous Technologies of America
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3930
- Decision date: 2008-08-29
Classification & Regulation
This clearance is catalogued under FDA product code NPL and 21 CFR 872.3930, within the Dental review panel as a Class II device.