510(k) K932078 ยท EBC Sealant, Pit And Fissure, And Conditioner
HELIOSEAL F
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Sep 15, 1993 |
| Received | Apr 29, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932078
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2015 | Ivoclar A. G. Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a s Terminated |
EBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.