Implant, Endosseous, Orthodontic
Regulation 872.3640
1510(k)s in 12 months (52 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in OAT
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomaterials Korea, Inc. | 4 | 0 |
| Straumann USA | 2 | 2 |
| Dentaurum | 3 | 0 |
| Bomei Co, Ltd. | 2 | 0 |
| D B Orthodontics, Ltd. | 2 | 0 |
| Leone S.P.A. | 2 | 0 |
| Osstem Implant Co., Ltd. | 2 | 0 |
| Syntec Scientific Corp. | 2 | 0 |
| Synthes (Usa) | 2 | 0 |
| Ace Surgical Supply Co., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2004 | K040469 | THE STRAUMANN ORTHO IMPLANT SYSTEM The Straumann Co. | OAT |
| Sep 30, 1998 | K982509 | ORTHO IMPLANT AND ACCESSORIES Straumann USA | OAT |
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