Device Classification Name |
Bracket, Ceramic, Orthodontic
|
510(k) Number |
K190608 |
Device Name |
Mei Ceramic Bracket |
Applicant |
Orthosun Co., Ltd. |
2F, 112, Pyeongni-gil, Gyeyang-gu |
Incheon,
KR
21008
|
|
Applicant Contact |
Ju-Sung Lee |
Correspondent |
Plus Global |
300 Atwood Street |
Pittsburgh,
PA
15213
|
|
Correspondent Contact |
Peter Chung |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 03/11/2019 |
Decision Date | 11/04/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|