The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Estheticone Non-rotational System.
| Device ID | K934827 |
| 510k Number | K934827 |
| Device Name: | BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Alan I Becker |
| Correspondent | Alan I Becker NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-08 |
| Decision Date | 1994-08-08 |