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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K221921
Device Name DTX Studio Clinic 3.0
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
411 17 Goteborg,  SE 402 26
Applicant Contact Wim Vrydag
Correspondent
Nobel Biocare c/o Medicim NV
Stationsstraat 102
Mechelen,  BE 2800
Correspondent Contact Wim Vrydag
Regulation Number892.2070
Classification Product Code
MYN  
Date Received07/01/2022
Decision Date 03/28/2023
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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