FDA 510(k) Application Details - K112307

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K112307
Device Name	Cement, Dental
Applicant	SHOFU DENTAL CORPORATION 1225 STONE DRIVE SAN MARCOS, CA 92078 US Other 510(k) Applications for this Company
Contact	DAVID P MORAIS 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	08/11/2011
Decision Date	03/28/2012
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