510(k) K112168 ยท EBF Material, Tooth Shade, Resin
COMPONEER
| Applicant | Coltene/Whaledent AG, Cuyahoga Falls OH, US |
| Decision | Substantially Equivalent, Nov 21, 2011 |
| Received | Jul 28, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112168
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.