K152518 is an FDA 510(k) clearance for the Vonflex S Putty. 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 30, 2015, 88 days after receiving the submission on September 3, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K152518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2015 |
| Decision Date | November 30, 2015 |
| Days to Decision | 88 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 |