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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K161488
Device Name ESTETICA Dental Treatment Unit and Accessories
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 Number872.6640
Classification Product Code
EIA  
Subsequent Product Code
EBW  
Date Received06/01/2016
Decision Date 12/08/2016
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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