510(k) K143694 ยท EBF Material, Tooth Shade, Resin
Rhondium One-Visit-Crown(OVC)
| Applicant | Rhondium, Ltd., Katikati, NZ |
| Decision | Substantially Equivalent, May 15, 2015 |
| Received | Dec 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2019 | RHONDIUM LIMITED Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand. Completed |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.