FDA 510(k) Application Details - K050750

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K050750
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS 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	03/23/2005
Decision Date	04/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review