FDA 510(k) Application Details - K032195

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K032195
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	DENTAURUM 10 PHEASANT RUN NEWTOWN, PA 18940 US Other 510(k) Applications for this Company
Contact	JAN A DOORSCHODT Other 510(k) Applications for this Contact
Regulation Number	872.3750   More FDA Info for this Regulation Number
Classification Product Code	DYH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2003
Decision Date	10/07/2003
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