FDA 510(k) Application Details - K090931

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K090931
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE BUERMOOS, SALZBURG A-5111 AT Other 510(k) Applications for this Company
Contact	JOHANN GEORG SCHARL 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	04/02/2009
Decision Date	12/15/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review