510(k) K102354 ยท EBF Material, Tooth Shade, Resin
GRANDIO SO HEAVY FLOW
| Applicant | Voco GmbH, Cuxhaven, DE |
| Decision | Substantially Equivalent, Nov 8, 2010 |
| Received | Aug 19, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102354
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Voco GmbH Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities i Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.