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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 K011560
Device Name TRUBYTE DENTURE BASE RESIN SYSTEM
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3760
Classification Product Code
EBI  
Date Received05/21/2001
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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