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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 K960823
Device Name PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
Applicant
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Applicant Contact P. JEFFREY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
York,  PA  17405 -0872
Correspondent Contact P. JEFFREY LEHN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received02/29/1996
Decision Date 04/26/1996
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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