The following data is part of a premarket notification filed by Bio-interfaces, Inc. with the FDA for Superior Endosseous Dental Implant System.
| Device ID | K884732 |
| 510k Number | K884732 |
| Device Name: | SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Contact | Hazel M Shumway |
| Correspondent | Hazel M Shumway BIO-INTERFACES, INC. 11095 FLINTKOTE AVE. San Diego, CA 92121 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-10 |
| Decision Date | 1989-05-18 |