FDA 510(k) Application Details - K132393

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K132393
Device Name	Cement, Dental
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	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2013
Decision Date	03/14/2014
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