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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K082198
Device Name DURASHIELD PLUS
Applicant
DENTSPLY INTL., INC.
SUSQUEHANNA COMMERCE CENTER
221 W PHILADELPHIA ST. STE 60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTL., INC.
SUSQUEHANNA COMMERCE CENTER
221 W PHILADELPHIA ST. STE 60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3260
Classification Product Code
LBH  
Date Received08/04/2008
Decision Date 10/29/2008
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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