K171200 is an FDA 510(k) clearance for the Grandio blocs. 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 August 10, 2017, 108 days after receiving the submission on April 24, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K171200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2017 |
| Decision Date | August 10, 2017 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| 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 |