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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K191385
Device Name BRILLIANT COMPONEER
Applicant
Coltene/Whaledent AG
Feldwiesenstrasse 20
Altstatten,  CH 9450
Applicant Contact Wolfgang Dorner
Correspondent
Coltene/Whaledent AG
Feldwiesenstrasse 20
Altstatten,  CH 9450
Correspondent Contact Wolfgang Dorner
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/23/2019
Decision Date 10/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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