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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 K103160
Device Name NUPRO MODEL 13016901
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 Number872.3260
Classification Product Code
LBH  
Date Received10/26/2010
Decision Date 01/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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