FDA 510(k) Application Details - K112665

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K112665
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	KEITH A BARRITT 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	09/13/2011
Decision Date	05/04/2012
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