The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Ball Attachment System.
| Device ID | K955372 |
| 510k Number | K955372 |
| Device Name: | BALL ATTACHMENT 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 | 1995-11-22 |
| Decision Date | 1996-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747012736 | K955372 | 000 |
| 07332747012620 | K955372 | 000 |
| 07332747012637 | K955372 | 000 |
| 07332747012644 | K955372 | 000 |
| 07332747012651 | K955372 | 000 |
| 07332747012668 | K955372 | 000 |
| 07332747012675 | K955372 | 000 |
| 07332747012682 | K955372 | 000 |
| 07332747012699 | K955372 | 000 |
| 07332747012705 | K955372 | 000 |
| 07332747012712 | K955372 | 000 |
| 07332747012729 | K955372 | 000 |
| 07332747012613 | K955372 | 000 |