Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K213026 |
Device Name |
Clear Aligner |
Applicant |
Shenzhen Meiming Dentistry Technology Co., Ltd |
Floor 3, Buliding D, Fuxinlin Industrial Park, Mati Pond, |
Gushu Community, Xixiang Street, Baoan Dis |
Shenzhen,
CN
518102
|
|
Applicant Contact |
Fei Hu |
Correspondent |
Shenzhen Meiming Dentistry Technology Co., Ltd |
Floor 3, Buliding D, Fuxinlin Industrial Park, Mati Pond, |
Gushu Community, Xixiang Street, Baoan Dis |
Shenzhen,
CN
518102
|
|
Correspondent Contact |
Fei Hu |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/21/2021 |
Decision Date | 08/16/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|