FDA 510(k) Application Details - K210373

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K210373
Device Name	Aligner, Sequential
Applicant	Shenzhen Yinuo Dental Technology Co.LTD Xinfeng Industry Park No.11,101-301,Xintian Community, Guanhu Street, Longhua Shenzhen 518000 CN Other 510(k) Applications for this Company
Contact	Mo Yuyum 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	02/08/2021
Decision Date	08/27/2021
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