510(k) K011491 ยท EBC Sealant, Pit And Fissure, And Conditioner
HELIOSEAL CLEAR CHROMA
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Aug 16, 2001 |
| Received | May 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011491
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.