FDA 510(k) Application Details - K250279

Device Classification Name	Cleanser, Root Canal   More FDA Info for this Device
510(K) Number	K250279
Device Name	Cleanser, Root Canal
Applicant	Belport Company, Inc., Gingi-Pak 4825 Calle Alto Camarillo, CA 93012 US Other 510(k) Applications for this Company
Contact	Peng Jingtian Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KJJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2025
Decision Date	07/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review