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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 K032892
Device Name MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17404
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17404
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/17/2003
Decision Date 09/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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