FDA 510(k) Application Details - K050959

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K050959
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. 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	872.3765   More FDA Info for this Regulation Number
Classification Product Code	EBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2005
Decision Date	05/11/2005
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