The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Drill Controller.
| Device ID | K931785 |
| 510k Number | K931785 |
| Device Name: | BRANEMARK SYSTEM DRILL CONTROLLER |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Alan I Becker |
| Correspondent | Alan I Becker 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 | 1993-04-09 |
| Decision Date | 1994-08-09 |