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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 K103027
Device Name ELECTROTORQUE TLC
Applicant
Kaltenbach & Voigt GmbH
1717 W. Collins
Orange,  CA  92687
Applicant Contact CLAUDIA ORTIZ
Correspondent
Kaltenbach & Voigt GmbH
1717 W. Collins
Orange,  CA  92687
Correspondent Contact CLAUDIA ORTIZ
Regulation Number872.4200
Classification Product Code
EBW  
Subsequent Product Code
EKX  
Date Received10/13/2010
Decision Date 08/19/2011
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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