FDA 510(k) Application Details - K193341

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K193341
Device Name	Controller, Foot, Handpiece And Cord
Applicant	Dentium Co., Ltd 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-Si 16229 KR Other 510(k) Applications for this Company
Contact	Sangwoo Lee Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2019
Decision Date	09/04/2020
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