Retainer, Screw Expansion, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (5 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in DYJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Brius Technologies Inc. | 0 | 3 |
| A Company, Inc. | 1 | 0 |
| Allesee Orthodontic Appliances | 0 | 1 |
| American Orthodontics | 1 | 0 |
| Cleft Palate Appliances, Inc. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Forestadent | 1 | 0 |
| Ormco Corporation | 0 | 1 |
| Sybron Dental Specialties | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 1997 | K970930 | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE Cleft Palate Appliances, Inc., CA | DYJ |
| Feb 3, 1994 | K935154 | DENTAURUM EXPANSION SCREWS Dentauraum, Inc. | DYJ |
| May 22, 1993 | K925088 | EXPANSION SCREWS Forestadent, DE | DYJ |
| Dec 20, 1991 | K912417 | MOLAR DISTALIZING ASSEMBLY American Orthodontics | DYJ |
| Nov 14, 1984 | K843705 | MANDIBULATOR JAW POSITIONER A Company, Inc. | DYJ |
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