K251239 is an FDA 510(k) clearance for the GrandioSO Unlimited. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on May 21, 2025, 29 days after receiving the submission on April 22, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K251239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2025 |
| Decision Date | May 21, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |