Aligner, Bracket, Orthodontic
Regulation 872.4565
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in ECQ
| Company | 510(k)s | Recalls |
|---|---|---|
| A Company, Inc. | 1 | 0 |
| Dentauraum, Inc. | 1 | 0 |
| Karl Storz Endoscopy America Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 1994 | K935153 | DENTAURUM BRACKET POSITIONING GAUGE Dentauraum, Inc. | ECQ |
| Apr 29, 1985 | K851454 | A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS A Company, Inc. | ECQ |
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