The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Branemark System Smiline Ii.
| Device ID | K944963 |
| 510k Number | K944963 |
| Device Name: | BRANEMARK SYSTEM SMILINE II |
| 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 | 1994-10-07 |
| Decision Date | 1995-02-17 |