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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 K103653
Device Name E3 TORQUE CONTROL MOTOR
Applicant
Dentsply International, Inc.
221 W. Philadelphia St., Suite 60
York,  PA  17401
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International, Inc.
221 W. Philadelphia St., Suite 60
York,  PA  17401
Correspondent Contact HELEN LEWIS
Regulation Number872.4200
Classification Product Code
EBW  
Date Received12/13/2010
Decision Date 05/26/2011
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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