FDA 510(k) Application Details - K223454

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K223454
Device Name	Aligner, Sequential
Applicant	Zhejiang Yinchili Medical Technology Co., Ltd. North 4F, No.239 Yatai Road Nanhu District Jiaxing 314000 CN Other 510(k) Applications for this Company
Contact	Xinyan Zhang 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	11/16/2022
Decision Date	04/17/2023
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