FDA 510(k) Application Details - K232978

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K232978
Device Name	Agent, Tooth Bonding, Resin
Applicant	Sino-Dentex Co., Ltd. 1000 Westgate Drive Suite #510k Saint Paul, MN 55114 US Other 510(k) Applications for this Company
Contact	Pengtao Yan 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	09/21/2022
Decision Date	09/22/2023
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	Y
Expedited Review