Bracket, Metal, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (103 all time)
0recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in EJF
| Company | 510(k)s | Recalls |
|---|---|---|
| American Orthodontics | 22 | 0 |
| Ormco Corp. | 8 | 2 |
| Flexmedics | 7 | 0 |
| Lancer Orthodontics, Inc. | 7 | 0 |
| Gac Intl., Inc. | 5 | 0 |
| Masel Industries, Inc. | 4 | 0 |
| Ortho Organizers, Inc. | 2 | 2 |
| Unitek Corp. | 4 | 0 |
| Ormco/Sybronendo | 0 | 3 |
| A Company, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 1980 | K801809 | ORTHODONTIC BRACKET/SPEED/HANSON SPEED Strite Industries , Ltd. | EJF |
| Mar 15, 1978 | K780170 | ORTHODONTIC BRACKET PADS Rocky Mountain Orthodontics, Inc. | EJF |
| Sep 30, 1977 | K771774 | NEW BASE FOR ORTHODONTIC APPLIANCES Gac Intl., Inc. | EJF |
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