K152615 is an FDA 510(k) clearance for the Vonflex S. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on November 3, 2016, 416 days after receiving the submission on September 14, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K152615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2015 |
| Decision Date | November 03, 2016 |
| Days to Decision | 416 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |