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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Caries Detector, Laser Light, Transmission
510(k) Number K250771
Device Name Primescan 2
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Diane Rutherford
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Diane Rutherford
Regulation Number872.1745
Classification Product Code
NTK  
Subsequent Product Code
NBL  
Date Received03/13/2025
Decision Date 08/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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