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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 WEST SKYHAWK DRIVE
WEST JORDAN,  UT  84084
Applicant Contact ROBERT K LARSEN
Correspondent
CAO GROUP, INC.
4628 WEST SKYHAWK DRIVE
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
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