FDA 510(k) Application Details - K153191

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K153191
Device Name	Material, Tooth Shade, Resin
Applicant	DENALI CORPORATION 134 OLD WASHINGTON STREET HANOVER, MA 02339 US Other 510(k) Applications for this Company
Contact	Jan G Stannard 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	11/03/2015
Decision Date	02/26/2016
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