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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 K151619
Device Name Prime&Bond Elect Universal Dental Adhesive
Applicant
Dentsply International, Inc.
221 W. Philadelphia St., Suite 60
York,  PA  17401
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International, Inc.
221 W. Philadelphia St., Suite 60
York,  PA  17401
Correspondent Contact HELEN LEWIS
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/16/2015
Decision Date 10/30/2015
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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