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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name dental image analyzer
De Novo Number DEN230035
Device Name DentalMonitoring
Requester
dental monitoring sas
75 rue de tocqueville
paris,  FR 75017
Contact isabelle puraye
Regulation Number872.1770
Classification Product Code
SBC  
Date Received05/04/2023
Decision Date 05/17/2024
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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