FDA 510(k) Application Details - K083062

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K083062
Device Name	Resin, Root Canal Filling
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	872.3820   More FDA Info for this Regulation Number
Classification Product Code	KIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/2008
Decision Date	03/12/2009
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