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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K170733
Device Name ScanX Intraoral View
Applicant
Duerr Dental AG
Hopfigheimer Strasse 17
Bietigheim-Bissingen,  DE D-74321
Applicant Contact Oliver Lange
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number872.1800
Classification Product Code
MUH  
Date Received03/10/2017
Decision Date 05/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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