The following data is part of a premarket notification filed by Vericom Co., Ltd. with the FDA for Vonflex S Bite.
| Device ID | K140966 |
| 510k Number | K140966 |
| Device Name: | VONFLEX S BITE |
| Classification | Material, Impression |
| Applicant | VERICOM CO., LTD. 48, Toegyegongdan 1-gil Chuncheon-si, Gangwon - Do, KR 200-944 |
| Contact | Myung-hwan Oh |
| Correspondent | Jay Hwang VERICOM CO., LTD. 2670 WALNUT AVE. SUITE K Tustin, CA 92780 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-15 |
| Decision Date | 2014-08-15 |