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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handpiece, air-powered, dental
510(k) Number K181110
Device Name PROPHYflex 4
Applicant
Kaltenbach & Voigt GmbH
Bismarckring 39
Biberach,  DE 88400
Applicant Contact Stefan Trampler
Correspondent
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte,  NC  28273
Correspondent Contact Frank Ray
Regulation Number872.4200
Classification Product Code
EFB  
Date Received04/27/2018
Decision Date 04/10/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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