FDA 510(k) Application Details - K240153

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K240153
Device Name	Agent, Tooth Bonding, Resin
Applicant	Liaoning Upcera Co., Ltd No. 122 Xianghuai Road, Economic Development Zone Benxi 117004 CN Other 510(k) Applications for this Company
Contact	Li Luo Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2024
Decision Date	10/02/2024
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