K103164 is an FDA 510(k) clearance for the VONFLEX HEAVY, VINFLEX LIGHT. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Vericom Co., Ltd. (Anyang-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on November 10, 2010, 14 days after receiving the submission on October 27, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K103164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2010 |
| Decision Date | November 10, 2010 |
| Days to Decision | 14 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 |