FDA 510(k) Application Details - K223365

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K223365
Device Name	Coating, Filling Material, Resin
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	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2022
Decision Date	03/27/2023
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