FDA 510(k) Application Details - K250009

Device Classification Name	Activator, Ultraviolet, For Polymerization   More FDA Info for this Device
510(K) Number	K250009
Device Name	Activator, Ultraviolet, For Polymerization
Applicant	Premium Plus (Dongguan) Limited Flat 101, No.122, Tianqiao Road, Changping Dongguan 523581 CN Other 510(k) Applications for this Company
Contact	Jessica Mao 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	01/02/2025
Decision Date	04/10/2025
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