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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K253565
Device Name SureSmile Software
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St.
York,  PA  17401
Applicant Contact John Van Hoven
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St.
York,  PA  17401
Correspondent Contact John Van Hoven
Regulation Number872.5470
Classification Product Code
PNN  
Date Received11/17/2025
Decision Date 03/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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