510(k) K162967 ยท EBF Material, Tooth Shade, Resin
nuance UNIVERSAL
| Applicant | Den-Mat Holdings, LLC, Lompoc CA, US |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Oct 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162967
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.