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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 K130680
Device Name ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
Applicant
Dentsoll, Inc.
8708 Capehart Cove
Austin,  TX  78733
Applicant Contact DAVID C FURR
Correspondent
Dentsoll, Inc.
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact DAVID C FURR
Regulation Number872.3760
Classification Product Code
EBI  
Date Received03/13/2013
Decision Date 07/26/2013
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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