FDA 510(k) Application Details - K210421

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K210421
Device Name	Material, Tooth Shade, Resin
Applicant	Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si 28161 KR Other 510(k) Applications for this Company
Contact	Kab Sun Lee Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/2021
Decision Date	06/28/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review