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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 K203156
Device Name DTX Studio Clinic
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
Goteborg,  SE SE-402 26
Applicant Contact Wim Vrydag
Correspondent
Nobel Biocare C/O Medicim NV
Stationsstraat 102
Mechelen,  BE 2800
Correspondent Contact Vladislavs Mihailovs
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/22/2020
Decision Date 11/20/2020
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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