FDA 510(k) Application Details - K150704

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K150704
Device Name	Cement, Dental
Applicant	KURARAY NORITAKE DENTAL, INC. Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda ku 1000004 JP Other 510(k) Applications for this Company
Contact	MICHIO TAKIGAWA 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	03/18/2015
Decision Date	08/21/2015
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