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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 K113608
Device Name DEFLEX
Applicant
Nuxen S.R.L.
9741 Juan B Justo
Buenos Aires,  AR C1408ALB
Applicant Contact HERNAN ILARI
Correspondent
Nuxen S.R.L.
9741 Juan B Justo
Buenos Aires,  AR C1408ALB
Correspondent Contact HERNAN ILARI
Regulation Number872.3760
Classification Product Code
EBI  
Date Received12/06/2011
Decision Date 04/10/2012
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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