510(k) K240660 ยท EBF Material, Tooth Shade, Resin
Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active
| Applicant | Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Sep 17, 2024 |
| Received | Mar 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240660
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.