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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 K962515
Device Name KERR ADVANCED ADHESIVE
Applicant
Kerr Dental Materials Center
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact WILLIAM R PIKE
Correspondent
Kerr Dental Materials Center
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact WILLIAM R PIKE
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/27/1996
Decision Date 08/01/1996
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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