The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Titanium Healing Abutments.
| Device ID | K925779 |
| 510k Number | K925779 |
| Device Name: | BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-16 |
| Decision Date | 1993-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747069624 | K925779 | 000 |
| 07332747003307 | K925779 | 000 |
| 07332747003314 | K925779 | 000 |
| 07332747003321 | K925779 | 000 |
| 07332747003338 | K925779 | 000 |
| 07332747003345 | K925779 | 000 |
| 07332747003376 | K925779 | 000 |
| 07332747003383 | K925779 | 000 |
| 07332747015867 | K925779 | 000 |
| 07332747015874 | K925779 | 000 |
| 07332747015881 | K925779 | 000 |
| 07332747015898 | K925779 | 000 |
| 07332747015904 | K925779 | 000 |
| 07332747015911 | K925779 | 000 |
| 07332747015928 | K925779 | 000 |
| 07332747015935 | K925779 | 000 |
| 07332747029215 | K925779 | 000 |
| 07332747069617 | K925779 | 000 |
| 07332747003291 | K925779 | 000 |