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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 K151088
Device Name DMRC Bulk Fill
Applicant
Danville Materials, LLC
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Applicant Contact DONG HUA
Correspondent
Danville Materials, LLC
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Correspondent Contact DONG HUA
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/23/2015
Decision Date 08/28/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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