FDA 510(k) Application Details - K222891

Device Classification Name	Varnish, Cavity   More FDA Info for this Device
510(K) Number	K222891
Device Name	Varnish, Cavity
Applicant	Guangzhou Beogene Biotech Co., Ltd Second floor, Building C, Self-compiled (1) Building No.2 Ruitai Road, Huangpu District Guangzhou 510540 CN Other 510(k) Applications for this Company
Contact	Duan Qiangqiang 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	09/23/2022
Decision Date	05/25/2023
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