The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Nobelpharma Ceraone Abutment System.
| Device ID | K910611 |
| 510k Number | K910611 |
| Device Name: | NOBELPHARMA CERAONE ABUTMENT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747016109 | K910611 | 000 |
| 07332747016093 | K910611 | 000 |