The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Hand Instrument.
| Device ID | K925774 |
| 510k Number | K925774 |
| Device Name: | BRANEMARK SYSTEM HAND INSTRUMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Thomas L Parker |
| Correspondent | Thomas L Parker 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 | 1992-11-16 |
| Decision Date | 1993-09-16 |