510(k) K922499 ยท EJF Bracket, Metal, Orthodontic
REFLECTIONS - CERAMIC DENTAL BRACKET
| Applicant | Cdb Corp., Wilmington NC, US |
| Decision | Substantially Equivalent, Jul 30, 1992 |
| Received | May 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922499
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2013 | Ultradent Products, Inc. Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017,
Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechan Terminated |
EJF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.