FDA 510(k) Application Details - K171147

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K171147
Device Name	Material, Tooth Shade, Resin
Applicant	Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 US Other 510(k) Applications for this Company
Contact	Ryan Hobson 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	04/19/2017
Decision Date	08/04/2017
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