Clearance Summary
APACERAM ARTIFICIAL DENTAL IMPLANT received FDA 510(k) clearance under submission number K885133, 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 1989-09-05.
- Submission: K885133
- 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: 1989-09-05
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.