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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 K083252
Device Name NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
Applicant
Dentalez Group, Stardental Division
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact DALE BRAAS
Correspondent
Dekra Certification B.V
Utrechtseweg 310
Arnhem,  NL NL-6812 AR
Correspondent Contact J.A. VAN VUGT
Regulation Number872.4200
Classification Product Code
EBW  
Date Received11/04/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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