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 Hydroxylapatite Dental Implant (type G).
| Device ID | K872089 |
| 510k Number | K872089 |
| Device Name: | APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. 7115 ORCHARD LAKE RD. SUITE 140 West Bloomfield, MI 48033 |
| Contact | A. D Rosati |
| Correspondent | A. D Rosati ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. 7115 ORCHARD LAKE RD. SUITE 140 West Bloomfield, MI 48033 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-08-14 |