FDA 510(k) Application Details - K160049

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K160049
Device Name	Material, Tooth Shade, Resin
Applicant	Heraeus Kulzer, LLC (Mitsui Chemicals Group) 4315 S. Lafayette Blvd South Bend, IN 46614 US Other 510(k) Applications for this Company
Contact	Jamie Cleveland 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	01/11/2016
Decision Date	11/15/2016
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