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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 K162967
Device Name nuance UNIVERSAL
Applicant
Den-Mat Holdings, LLC
1017 W. Central Ave.
Lompoc,  CA  93436
Applicant Contact Helen Ragus
Correspondent
Den-Mat Holdings, LLC
1017 W. Central Ave.
Lompoc,  CA  93436
Correspondent Contact Helen Ragus
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/24/2016
Decision Date 03/24/2017
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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