Bracket, Ceramic, Orthodontic
Regulation 872.5470
0510(k)s in 12 months (60 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in NJM
| Company | 510(k)s | Recalls |
|---|---|---|
| American Orthodontics | 3 | 0 |
| Biocetec Co., Ltd. | 3 | 0 |
| Cdb Corporation | 3 | 0 |
| Lightforce Orthodontics | 3 | 0 |
| Ormco Corp. | 3 | 0 |
| Tomy, Inc. | 3 | 0 |
| 3M Unitek | 2 | 0 |
| Dentsply Interntional | 2 | 0 |
| Dentsply Intl. | 2 | 0 |
| Gni Co., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2013 | Ultradent Products, Inc. Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets
Avex CX2 ceramic brackets are intended for use in orthodontic treatment. Terminated |
NJM | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.