FDA 510(k) Application Details - K091913

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K091913
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	BY DENTAL SRL VIA VECCHIA PROV. LE LUCCHESE 49/FG SERRAVALLE POLI; PISTOIA 51030 IT Other 510(k) Applications for this Company
Contact	DANIELE POLI 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	06/30/2009
Decision Date	10/30/2009
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	N
Expedited Review