FDA 510(k) Application Details - K130486

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K130486
Device Name	Agent, Tooth Bonding, Resin
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	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2013
Decision Date	06/20/2013
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