FDA 510(k) Application Details - K134021

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K134021
Device Name	Cement, Dental
Applicant	SPIDENT CO., LTD. 2115 LINWOOD AVE 5TH FLOOR FORT LEE, NJ 07024 US Other 510(k) Applications for this Company
Contact	LENA PAK 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	12/30/2013
Decision Date	06/10/2014
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