The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System 4.00 Mm Fixture.
| Device ID | K925764 |
| 510k Number | K925764 |
| Device Name: | BRANEMARK SYSTEM 4.00 MM FIXTURE |
| 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 | 1992-11-13 |
| Decision Date | 1993-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747014839 | K925764 | 000 |