FDA 510(k) Application Details - K211259

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K211259
Device Name	Material, Tooth Shade, Resin
Applicant	Cosmedent, Inc 401 North Michigan Avenue, Suite 2500 Chicago, IL 60611 US Other 510(k) Applications for this Company
Contact	Gary Chuven 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	04/26/2021
Decision Date	06/24/2021
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