| K-number | K251239 |
| Device name | GrandioSO Unlimited |
| Applicant | Voco GmbH |
| Product code | EBF |
| Device class | Class II |
| Decision date | May 21, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3690 |
GrandioSO Unlimited is a tooth shade resin material (composite) used for dental restorations including Class I to V cavities, repair of traumatically damaged teeth, cosmetic veneering, core buildups under crowns, and other restorative dental applications. It is indicated for use on both permanent and deciduous teeth.
Not stated in this summary.
Not stated in this summary.
Not stated in this summary. The document confirms substantial equivalence to legally marketed predicate devices but does not provide the specific comparative analysis, predicate device identification, or technical/performance reasoning that would constitute the SE argument itself.
View the full FDA submission: accessdata.fda.gov