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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K251811
Device Name Motor and Apex Module (MaAM)
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 Number872.4200
Classification Product Code
EBW  
Subsequent Product Codes
EKX   LQY  
Date Received06/12/2025
Decision Date 08/25/2025
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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