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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 K021805
Device Name SEAL & PROTECT PROTECTIVE SEALANT
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 Number872.3260
Classification Product Code
LBH  
Date Received06/03/2002
Decision Date 08/19/2002
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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