510(k) K003034 ยท EBF Material, Tooth Shade, Resin
COLTENE AURA COMPOMER RESTORATIVE SYSTEM
| Applicant | Coltene/Whaledent, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Nov 30, 2000 |
| Received | Sep 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003034
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.