510(k) K051867 ยท EBF Material, Tooth Shade, Resin
GRANDIO
| Applicant | Voco GmbH, Bend OR, US |
| Decision | Substantially Equivalent, Jul 27, 2005 |
| Received | Jul 11, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2026 | Henry Schein Inc. Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes:
1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145
2) 949-3595, Mfr Product Code 1841; Lots 25390 Open, Classified |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.