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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2013 | Ormco/Sybronendo Brand Name: Vector TAS 8mm Screw.
The Device Listing Number is E670535.
Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate th Terminated |
OAT | None listed |
| Dec 4, 2007 | Straumann USA LLC Straumann Palatal Implant , 4.8 L 4.2 mm,
Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 Terminated |
OAT | K060062 |
| Dec 4, 2007 | Straumann USA LLC Straumann Palatal Implant , 04.1 L 4.2 mm,
Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008 Terminated |
OAT | K060062 |
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