510(k) K103528 ยท EBF Material, Tooth Shade, Resin
IPS EMPRESS DIRECT FLOW
| Applicant | Ivoclar Vivadent, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Feb 25, 2011 |
| Received | Nov 30, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103528
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.