FDA 510(k) Application Details - K101612

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K101612
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	DISCUS DENTAL, LLC 8550 HIGUERA ST. CULVER CITY, CA 90232 US Other 510(k) Applications for this Company
Contact	WINKIE WONG Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2010
Decision Date	06/30/2010
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	Y
Expedited Review