510(k) K254283 · EIH Powder, Porcelain
BruxZir® Shaded 16 PLUS
| Applicant | Prismatik Dentalcraft, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 30, 2026 |
| Received | Dec 31, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K254283
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.