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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 K092616
Device Name ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045
Applicant
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Applicant Contact ROBERT K LARSEN
Correspondent
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Correspondent Contact ROBERT K LARSEN
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received08/26/2009
Decision Date 10/21/2009
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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