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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 K122331
Device Name CAVITY VARNISH
Applicant
DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST., SE 60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST., SE 60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3260
Classification Product Code
LBH  
Date Received08/02/2012
Decision Date 10/15/2012
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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