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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 K181432
Device Name ProVectra 3D Prime with VistaSoft
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 Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
LLZ  
Date Received06/01/2018
Decision Date 08/02/2018
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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