Clearance Summary
ADI/B/*/HA-2 STAGE OSSEO. HYDRO. DENTAL IMPLANT received FDA 510(k) clearance under submission number K873939, sponsored by Anchor Implants , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-03-15.
- Submission: K873939
- Applicant / Sponsor: Anchor Implants , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1988-03-15
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.