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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
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