The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Cera One Abutment System.
| Device ID | K961737 |
| 510k Number | K961737 |
| Device Name: | CERA ONE ABUTMENT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| 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 |
|---|---|---|
| 07332747015065 | K961737 | 000 |
| 07332747015058 | K961737 | 000 |
| 07332747000610 | K961737 | 000 |
| 07332747000603 | K961737 | 000 |
| 07332747000597 | K961737 | 000 |
| 07332747000580 | K961737 | 000 |
| 07332747000573 | K961737 | 000 |
| 07332747000566 | K961737 | 000 |
| 07332747000559 | K961737 | 000 |