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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 K121880
Models 85072, 89107, 89463, 93885, 93886
Device Name DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
Original Applicant
DANVILLE MATERIALS, INC.
3420 fostoria way ste a200
san ramon,  CA  94583
Original Contact lindsay tilton
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/28/2012
Decision Date 09/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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