510(k) K130924 ยท EIH Powder, Porcelain
BRUXZIR SHADED
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 16, 2013 |
| Received | Apr 3, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130924
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2016 | Prismatik Dentalcraft, Inc BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006
The device is indicated for use by dental technicians in the construction of custom made Terminated |
EIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.