K102354 is an FDA 510(k) clearance for the GRANDIO SO HEAVY FLOW. 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 November 8, 2010, 81 days after receiving the submission on August 19, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K102354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2010 |
| Decision Date | November 08, 2010 |
| Days to Decision | 81 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |