FDA 510(k) Application Details - K123070

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K123070
Device Name	X-Ray, Tomography, Computed, Dental
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	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2012
Decision Date	03/15/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review