FDA 510(k) Application Details - K130485

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K130485
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 CUXHAVEN D-27472 DE Other 510(k) Applications for this Company
Contact	T. GERKENSMEIER Other 510(k) Applications for this Contact
Regulation Number	872.3765   More FDA Info for this Regulation Number
Classification Product Code	EBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2013
Decision Date	02/11/2014
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