510(k) K012794 ยท EBF Material, Tooth Shade, Resin
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT
| Applicant | Prime Dental Manufacturing, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Nov 5, 2001 |
| Received | Aug 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012794
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.