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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 K964525
Device Name PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
Applicant
Dentsply Intl.
500 W. College Ave.
York,  PA  17405
Applicant Contact P. JEFFERY LEHN
Correspondent
Dentsply Intl.
500 W. College Ave.
York,  PA  17405
Correspondent Contact P. JEFFERY LEHN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/12/1996
Decision Date 01/22/1997
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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