Device Classification Name |
Aligner, Sequential
More FDA Info for this Device |
510(K) Number |
K192767 |
Device Name |
Aligner, Sequential |
Applicant |
Royal Dental Lab
F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue
Industry Park, Bantian, Lon
Shenzhen 518129 CN
Other 510(k) Applications for this Company
|
Contact |
Mo Yuyun
Other 510(k) Applications for this Contact |
Regulation Number |
872.5470
More FDA Info for this Regulation Number |
Classification Product Code |
NXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/30/2019 |
Decision Date |
01/08/2020 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
DE - Dental |
Review Advisory Committee |
DE - Dental |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|