510(k) K013400 ยท EBF Material, Tooth Shade, Resin
SYNERGY FLOW
| Applicant | Coltene/Whaledent, Inc., Mahwah NJ, US |
| Decision | Substantially Equivalent, Dec 10, 2001 |
| Received | Oct 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013400
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.