FDA 510(k) Application Details - K192273

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K192273
Device Name	Agent, Tooth Bonding, Resin
Applicant	Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si 28161 KR Other 510(k) Applications for this Company
Contact	Kab Sun Lee 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	08/22/2019
Decision Date	02/07/2020
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