FDA 510(k) Application Details - K100606

Device Classification Name	Handpiece, Air-Powered, Root Canal Irrigation   More FDA Info for this Device
510(K) Number	K100606
Device Name	Handpiece, Air-Powered, Root Canal Irrigation
Applicant	REDENT NOVA LTD COLUMBIA SQUARE 555 13TH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	JONATHAN S KAHAN Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	NYL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2010
Decision Date	05/28/2010
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