Bracket, Plastic, Orthodontic
Regulation 872.5470
1510(k)s in 12 months (42 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in DYW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ormco Corp. | 9 | 4 |
| Sybron Dental Specialties | 3 | 0 |
| Ultradent Products, Inc. | 3 | 0 |
| Ortho Organizers, Inc. | 2 | 0 |
| Unitek Corp. | 2 | 0 |
| Advanced Orthodontics Systems, Inc. | 1 | 0 |
| American Orthodontics | 1 | 0 |
| Biomers Product, LLC | 1 | 0 |
| Biomers Products, LLC | 1 | 0 |
| Blue Sky Bio | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2014 | Ormco/Sybronendo Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013.
Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an arc Terminated |
DYW | K943245 |
| Nov 16, 2011 | Ormco Corporation Spirit MB Brackets, part #494-1211.
The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Brac Terminated |
DYW | K943245 |
| Nov 16, 2011 | Ormco Corporation Spirit MB Brackets, part #494-1210.
The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Brac Terminated |
DYW | K943245 |
| Nov 26, 2005 | Ormco Corporation Damon 3 Bracket
Upper Right lateral .022 slot
Part Number 491-4211
Lot Number 100514071 and 100512012 Terminated |
DYW | K052477 |
| Nov 26, 2005 | Ormco Corporation Damon 3 Bracket
Upper Right lateral .022 slot
Part Number 491-4210
Lot Number100512025 and 100512020 Terminated |
DYW | K052477 |
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