FDA 510(k) Application Details - K083766

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K083766
Device Name	Cement, Dental
Applicant	S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 ELMSHORN D-25335 DE Other 510(k) Applications for this Company
Contact	CHRISTIAN BOETTCHER 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	12/18/2008
Decision Date	03/02/2009
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