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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 K142880
Device Name DMRC Light Cure Orthodontic Adhesive System
Applicant
Daville Materials, LLC
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Applicant Contact Dong Hua
Correspondent
Daville Materials, LLC
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Correspondent Contact Dong Hua
Regulation Number872.3750
Classification Product Code
DYH  
Date Received10/02/2014
Decision Date 02/04/2015
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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