FDA 510(k) Application Details - K242386

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K242386
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	GENOSS Co., Ltd. 12F, 76, Changnyong-daero 256beon-gil, Yeongtong-gu Manufacturing site: 3F, 4F, 5F, D-factory, 56, Changnyong-da Suwon-si CN Other 510(k) Applications for this Company
Contact	Jiyeon Lee Other 510(k) Applications for this Contact
Regulation Number	872.6070   More FDA Info for this Regulation Number
Classification Product Code	EBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/2024
Decision Date	05/05/2025
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