FDA 510(k) Application Details - K231060

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K231060
Device Name	Varnish, Cavity
Applicant	Belport Company, Inc., Gingi-Pak 4825 Calle Alto Camarillo, CA 93012 US Other 510(k) Applications for this Company
Contact	Jingtian Peng Other 510(k) Applications for this Contact
Regulation Number	872.3260   More FDA Info for this Regulation Number
Classification Product Code	LBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2023
Decision Date	06/13/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review