FDA 510(k) Application Details - K072107

Device Classification Name	Scaler, Ultrasonic   More FDA Info for this Device
510(K) Number	K072107
Device Name	Scaler, Ultrasonic
Applicant	SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 BENSHEIM D-64625 DE Other 510(k) Applications for this Company
Contact	FRITZ KOLLE Other 510(k) Applications for this Contact
Regulation Number	872.4850   More FDA Info for this Regulation Number
Classification Product Code	ELC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2007
Decision Date	02/14/2008
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