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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K051707
Device Name ECLIPSE BONDING AGENT
Applicant
Dentsply Intl.
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply Intl.
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EBI  
Date Received06/27/2005
Decision Date 07/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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