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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K143290
Device Name DBSWIN and VistaEasy Imaging Software
Applicant
Durr Dental AG
Hopfigheimer Strasse 17
Bietigheim-Bissingen,  DE D-74321
Applicant Contact Oliver Lange
Correspondent
Air Techniques, Inc.
1295 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact Suzanne Lucas
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/17/2014
Decision Date 02/18/2016
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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