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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K143465
Device Name MASTERmatic LUX
Applicant
Kaltenbach & Voigt GmbH
Bismarckring 39
Biberach,  DE 88400
Applicant Contact Stefan Trampler
Correspondent
Kaltenbach & Voigt GmbH
Bismarckring 39
Biberach,  DE 88400
Correspondent Contact Stefan Trampler
Regulation Number872.4200
Classification Product Code
EFA  
Date Received12/04/2014
Decision Date 04/09/2015
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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