K140966 is an FDA 510(k) clearance for the VONFLEX S BITE. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Vericom Co., Ltd. (Chuncheon-Si, Gangwon - Do, KR). The FDA issued a Cleared decision on August 15, 2014, 122 days after receiving the submission on April 15, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K140966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2014 |
| Decision Date | August 15, 2014 |
| Days to Decision | 122 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 |