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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
Device Name DEFLEX ACRILATO
Applicant
NUXEN S.R.L.
J B JUSTO 9741, PB
BUENOS AIRES,  AR C1408ALB
Applicant Contact HERNAN ILARI
Correspondent
NUXEN S.R.L.
J B JUSTO 9741, PB
BUENOS AIRES,  AR C1408ALB
Correspondent 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 (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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