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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 K071500
Device Name NANO-BOND II ADHESIVE SYSTEM
Applicant
Pentron Clinical Technologies
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Pentron Clinical Technologies
11234 El Camino Real
Suite 200
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EMA  
Date Received05/31/2007
Decision Date 08/10/2007
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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