FDA 510(k) Application Details - K222308

Device Classification Name	Aligner, Sequential   More FDA Info for this Device
510(K) Number	K222308
Device Name	Aligner, Sequential
Applicant	Nanjing Jiahe Dental Technology Co., Ltd. Room 201, Building 2, No.2 Shuanglong Street, Qinhuai Distrit Nanjing 210000 CN Other 510(k) Applications for this Company
Contact	Charles Shen 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	08/01/2022
Decision Date	12/20/2022
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