510(k) K813015 ยท EBC Sealant, Pit And Fissure, And Conditioner
HELIOSEAL
| Applicant | Vivadent (Usa), Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 2, 1981 |
| Received | Oct 27, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2016 | Ivoclar Vivadent, Inc. Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant Terminated |
EBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.