The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System-5.0mm Fixture.
| Device ID | K911961 |
| 510k Number | K911961 |
| Device Name: | BRANEMARK SYSTEM-5.0MM FIXTURE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-02 |
| Decision Date | 1991-07-25 |