510(k) K230644 ยท EBF Material, Tooth Shade, Resin
Signum opaque F
| Applicant | Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Sep 7, 2023 |
| Received | Mar 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230644
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.