FDA 510(k) Application Details - K974458

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K974458
Device Name	Cement, Dental
Applicant	ESPE DENTAL-MEDIZIN GMBH & CO.KG. ESPE PLATZ SEEFELD D-82229 DE Other 510(k) Applications for this Company
Contact	BARBARA WAGNER-SCHUH 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	11/25/1997
Decision Date	02/02/1998
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