FDA 510(k) Application Details - K150393

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K150393
Device Name	Material, Tooth Shade, Resin
Applicant	IVOCLAR VIVADENT AG BENDERERSTRASSE 2 SCHAAN FL-9494 LI Other 510(k) Applications for this Company
Contact	SANDRA CAKEBREAD 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	02/18/2015
Decision Date	06/09/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review