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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
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