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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K250755
Device Name DS Core Diagnosis
Applicant
Dentsply Sirona Inc.
221 West Philadelphia St.
Suite 60W
York,  PA  17401
Applicant Contact Deepthi Paknikar
Correspondent
Dentsply Sirona Inc.
221 West Philadelphia St.
Suite 60W
York,  PA  17401
Correspondent Contact Deepthi Paknikar
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/12/2025
Decision Date 08/12/2025
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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