Clearance Summary
REPLACE TITANIUM IMPLANT SYSTEM received FDA 510(k) clearance under submission number K964220, sponsored by Steri-Oss, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1997-03-05.
- Submission: K964220
- Applicant / Sponsor: Steri-Oss, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1997-03-05
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.