The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Temporary Solutions.
| Device ID | K925766 |
| 510k Number | K925766 |
| Device Name: | BRANEMARK SYSTEM TEMPORARY SOLUTIONS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Contact | Alan I Becker |
| Correspondent | Alan I Becker NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| 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 | 1994-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747009194 | K925766 | 000 |
| 07332747009187 | K925766 | 000 |
| 07332747009170 | K925766 | 000 |
| 07332747009163 | K925766 | 000 |
| 07332747009156 | K925766 | 000 |
| 07332747009149 | K925766 | 000 |
| 07332747024050 | K925766 | 000 |