FDA 510(k) Application Details - K042806

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K042806
Device Name	Agent, Tooth Bonding, Resin
Applicant	CAVEX HOLLAND B.V. HARMENJANSWEG 19-21 P.O. BOX 852 HAARLEM (HOLLAND) 2003 RW NL Other 510(k) Applications for this Company
Contact	RICHARD WOORTMAN 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	10/12/2004
Decision Date	11/24/2004
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