The following data is part of a premarket notification filed by Pacific Implant, Inc. with the FDA for Intraosseous Dental Implant.
| Device ID | K813227 |
| 510k Number | K813227 |
| Device Name: | INTRAOSSEOUS DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PACIFIC IMPLANT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-10 |
| Decision Date | 1981-12-31 |