FDA 510(k) Application Details - K130125

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K130125
Device Name	Resin, Root Canal Filling
Applicant	S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN ROBERT-BOSCH-STRASSE 2 ELMSHORN, SCHLESWIG-HOLSTEIN 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	01/17/2013
Decision Date	07/24/2013
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