The following data is part of a premarket notification filed by Asahi Optical Co. C/o Rosati Associates, P.c. with the FDA for Apaceram Artificial Dental Implant.
| Device ID | K885133 |
| 510k Number | K885133 |
| Device Name: | APACERAM ARTIFICIAL DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. ATTORNEY & COUNSELOR AT LAW 31815 SOUTHFIELD ROAD - #15 Birmingham, MI 48009 |
| Contact | Ursu, Dds |
| Correspondent | Ursu, Dds ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. ATTORNEY & COUNSELOR AT LAW 31815 SOUTHFIELD ROAD - #15 Birmingham, MI 48009 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-09-05 |