The following data is part of a premarket notification filed by Perioseal with the FDA for The Perioseal Dental Implant.
| Device ID | K965032 |
| 510k Number | K965032 |
| Device Name: | THE PERIOSEAL DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | PERIOSEAL 10319 WEST MARKHAM, SUITE 300 Little Rock, AR 72205 |
| Contact | Donald P Callan |
| Correspondent | Donald P Callan PERIOSEAL 10319 WEST MARKHAM, SUITE 300 Little Rock, AR 72205 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-17 |
| Decision Date | 1997-08-20 |