510(k) K912485 ยท ELW Material, Impression
COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
| Applicant | Coltene/Whaledent, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jul 25, 1991 |
| Received | Jun 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912485
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.