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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 K223142
Device Name Coltolux Comfort LED Curing Light
Applicant
Dent4you AG
Bahnhofstrasse 2
Heerbrugg,  CH 9435
Applicant Contact Dr. Tricia Cregger
Correspondent
Dent4you AG
Bahnhofstrasse 2
Heerbrugg,  CH 9435
Correspondent Contact Dr. Tricia Cregger
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/04/2022
Decision Date 12/22/2022
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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