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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
Predetermined Change
Control Plan Authorized		 No
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