Device Classification Name |
aligner, sequential
|
510(k) Number |
K203688 |
Device Name |
Clear Aligner |
Applicant |
Wuxi EA Medical Instruments Technologies Limited. |
No. 1619, Huishan Avenue, Huishan Economic Development Zone |
Wuxi,
CN
214174
|
|
Applicant Contact |
Yan He |
Correspondent |
Shanghai Sungo Management Consulting Company Limited |
14th Floor, 1500# Central Avenue |
Shanghai,
CN
200122
|
|
Correspondent Contact |
Ivy Wang |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 12/17/2020 |
Decision Date | 10/08/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|