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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2008 | K081415 | DAMON 4CLEAR Ormco Corp. | NJM |
| Aug 4, 2008 | K080749 | RADIANCE American Orthodontics | NJM |
| Dec 18, 2007 | K073045 | SAPPHIRE CERAMIC BRACKET Ortho Technology, Inc. | NJM |
| Oct 18, 2006 | K062305 | CLARITY MODIFIED CERAMIC BRACKETS 3M Unitek | NJM |
| Apr 10, 2006 | K060837 | IN-OVATION C Dentsply International | NJM |
| Sep 23, 2005 | K052245 | ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS Lar Mfg., LLC | NJM |
| Nov 4, 2004 | K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY Dentsply Intl. | NJM |
| Aug 30, 2004 | K042178 | ORTHODONTIC CERAMIC BRACKETS Dentsply Intl. | NJM |
| May 3, 1995 | K950992 | CERAMAFLEX BRACKET SYSTEM Tp Orthodontics, Inc. | NJM |
| Aug 6, 1990 | K902075 | INTRIGUE CERAMIC BRACKET Lancer Orthodontics, Inc. | NJM |
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