FDA 510(k) Application Details - K203688

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K203688
Device Name	Aligner, Sequential
Applicant	Wuxi EA Medical Instruments Technologies Limited. No. 1619, Huishan Avenue, Huishan Economic Development Zone Wuxi 214174 CN Other 510(k) Applications for this Company
Contact	Yan He 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	12/17/2020
Decision Date	10/08/2021
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