Clearance Summary
APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G) received FDA 510(k) clearance under submission number K872089, sponsored by Asahi Optical Co. C/O Rosati Associates, P.C.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-08-14.
- Submission: K872089
- Applicant / Sponsor: Asahi Optical Co. C/O Rosati Associates, P.C.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1987-08-14
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.