510(k) K974906 ยท KLE Agent, Tooth Bonding, Resin
ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM
| Applicant | Coltene/Whaledent, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Mar 24, 1998 |
| Received | Dec 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974906
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.