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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Fluorescence Caries Detection
510(k) Number K242103
Device Name TRIOS Ready Tip
Applicant
3Shape TRIOS A/S
Holmens Kanal 7
Copenhagen,  DK Dk-1060
Applicant Contact Klaus Rudbaek Hoj
Correspondent
3Shape TRIOS A/S
Holmens Kanal 7
Copenhagen,  DK Dk-1060
Correspondent Contact Klaus Rudbaek Hoj
Regulation Number872.1745
Classification Product Code
NBL  
Date Received07/18/2024
Decision Date 04/04/2025
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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