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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name resin, denture, relining, repairing, rebasing
510(k) Number K113788
Models ROSA SUAVE (SOFT PINK), TRANSPARENTE (TRANSPARENT)
Device Name DEFLEX ACRILATO
Original Applicant
NUXEN S.R.L.
j b justo 9741, pb
buenos aires,  AR c1408alb
Original Contact hernan ilari
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received12/22/2011
Decision Date 03/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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