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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K103711
Device Name ORTHOPHOS XG 3D / CEPH
Applicant
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE 64625
Applicant Contact FRITZ KOLLE
Correspondent
Sirona Dental Systems GmbH
Fabrikstrasse 31
Bensheim,  DE 64625
Correspondent Contact FRITZ KOLLE
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/20/2010
Decision Date 03/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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