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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 K190629
Device Name DBSWIN and VISTAEASY Imaging Software
Applicant
Durr Dental SE
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 Number892.2050
Classification Product Code
LLZ  
Date Received03/12/2019
Decision Date 04/01/2019
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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