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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adhesive, bracket and tooth conditioner, resin
510(k) Number K142886
Device Name DMRC Self-Cure Bracket Adhesive One Step and Primer
Applicant
DANVILLE MATERIALS, LLC.
3420 Fostoria Way Ste A200
SAN RAMON,  CA  94583
Applicant Contact Dong Hua
Correspondent
DANVILLE MATERIALS, LLC.
3420 Fostoria Way Ste A200
SAN RAMON,  CA  94583
Correspondent Contact Dong Hua
Regulation Number872.3750
Classification Product Code
DYH  
Date Received10/02/2014
Decision Date 03/18/2015
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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