FDA 510(k) Application Details - K083252

Device Classification Name	Controller, Foot, Handpiece And Cord   More FDA Info for this Device
510(K) Number	K083252
Device Name	Controller, Foot, Handpiece And Cord
Applicant	DENTALEZ GROUP, STARDENTAL DIVISION 1816 COLONIAL VILLAGE LN. LANCASTER, PA 17601 US Other 510(k) Applications for this Company
Contact	DALE BRAAS 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	11/04/2008
Decision Date	02/18/2009
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	Y
Expedited Review