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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K233865
Device Name X-Smart Pro; X-Smart Pro+
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Laura Sorbin
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Laura Sobrin
Regulation Number872.4200
Classification Product Code
EKX  
Subsequent Product Code
LQY  
Date Received12/06/2023
Decision Date 07/24/2024
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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