510(k) K113334 ยท NJM Bracket, Ceramic, Orthodontic
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
| Applicant | Opal Orthodontics by Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Feb 3, 2012 |
| Received | Nov 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113334
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.