FDA 510(k) Application Details - K103653

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K103653
Device Name	Controller, Foot, Handpiece And Cord
Applicant	DENTSPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA ST. SUITE 60 YORK, PA 17401 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2010
Decision Date	05/26/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review