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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K100540
Device Name ASCENT F-COAT MODEL: 006-00097
Applicant
CAO GROUP, INC.
4628 WEST SKYHAWK DRIVE
WEST JORDAN,  UT  84084
Applicant Contact ROBERT LARSEN
Correspondent
CAO GROUP, INC.
4628 WEST SKYHAWK DRIVE
WEST JORDAN,  UT  84084
Correspondent Contact ROBERT LARSEN
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/25/2010
Decision Date 09/23/2010
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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