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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K000996
Device Name TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17405
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17405
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3520
Classification Product Code
EFT  
Date Received03/28/2000
Decision Date 06/16/2000
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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