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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name activator, ultraviolet, for polymerization
510(k) Number K150585
Device Name Ascent 3D
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 Number872.6070
Classification Product Code
EBZ  
Date Received03/09/2015
Decision Date 12/31/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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