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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 K091300
Device Name ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
Applicant
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Applicant Contact ROBERT LARSON
Correspondent
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Correspondent Contact ROBERT LARSON
Regulation Number872.3200
Classification Product Code
KLE  
Date Received05/04/2009
Decision Date 07/23/2009
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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