Device Classification Name |
bracket, ceramic, orthodontic
|
510(k) Number |
K220689 |
Device Name |
Vatech Clismile |
Applicant |
Rayence Co.,Ltd |
14, Samsung 1-ro, 1gil |
Hwaseong-si,
KR
445-170
|
|
Applicant Contact |
Kevin Kim |
Correspondent |
Mtech Group |
7505 Fannin St. Ste 610 |
Houston,
TX
77054
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 03/09/2022 |
Decision Date | 05/06/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|