FDA 510(k) Application Details - K053392

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K053392
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	MICHAEL SUS 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	12/05/2005
Decision Date	12/15/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review