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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser Activator For Polymerization
510(k) Number K201904
Device Name Monet Curing Laser
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 Number872.6070
Classification Product Code
QNF  
Subsequent Product Code
GEX  
Date Received07/09/2020
Decision Date 11/24/2020
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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