FDA 510(k) Application Details - K223518

Device Classification Name	More FDA Info for this Device
510(K) Number	K223518
Device Name	iOrtho
Applicant	Shanghai EA Medical Instruments Co., Ltd. No.1619 Huishan Avenue, Huishan Economic Development Zone Wuxi CN Other 510(k) Applications for this Company
Contact	Jessica Luo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2022
Decision Date	06/13/2023
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