510(k) K884588 ยท EBF Material, Tooth Shade, Resin
HELIOMOLAR(R) DENTAL RESTORATIVE
| Applicant | Williams Dental Co., Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jan 27, 1989 |
| Received | Nov 2, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 Terminated |
EBF | None listed |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 Terminated |
EBF | None listed |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 Terminated |
EBF | None listed |
| Aug 3, 2017 | Ivoclar Vivadent, Inc. Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.