Device Classification Name |
Aligner, Sequential
|
510(k) Number |
K192767 |
Device Name |
Clear Aligner |
Applicant |
Royal Dental Lab |
F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue |
Industry Park, Bantian, Lon |
Shenzhen,
CN
518129
|
|
Applicant Contact |
Mo Yuyun |
Correspondent |
Feiying Drug & Medical Consulting Technical Service Group |
B-3F-3005, Bldg I, Southward Ruifeng Business Center, No.22 |
Guimiao Rd. |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Becky Chen |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 09/30/2019 |
Decision Date | 01/08/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|