The following data is part of a premarket notification filed by Rayence Co.,ltd with the FDA for Vatech Clismile.
| Device ID | K220689 |
| 510k Number | K220689 |
| Device Name: | Vatech Clismile |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | Rayence Co.,Ltd 14, Samsung 1-ro, 1gil Hwaseong-si, KR 445-170 |
| Contact | Kevin Kim |
| Correspondent | Dave Kim Mtech Group 7505 Fannin St. Ste 610 Houston, TX 77054 |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-09 |
| Decision Date | 2022-05-06 |