The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Miruscone Abutment System.
| Device ID | K961728 |
| 510k Number | K961728 |
| Device Name: | MIRUSCONE ABUTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Contact | Mary Edwards |
| Correspondent | Mary Edwards NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-03 |
| Decision Date | 1996-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747017748 | K961728 | 000 |
| 07332747003437 | K961728 | 000 |
| 07332747003444 | K961728 | 000 |
| 07332747003505 | K961728 | 000 |
| 07332747003512 | K961728 | 000 |
| 07332747003529 | K961728 | 000 |
| 07332747017670 | K961728 | 000 |
| 07332747017687 | K961728 | 000 |
| 07332747017694 | K961728 | 000 |
| 07332747017724 | K961728 | 000 |
| 07332747017731 | K961728 | 000 |
| 07332747003420 | K961728 | 000 |