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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 K223470
Device Name C50
Applicant
Sopro
Zac Athelia Iv Ave. Des Genevriers
La Ciotat,  FR 13705
Applicant Contact Kim Rouahi
Correspondent
Sopro
Zac Athelia Iv Ave. Des Genevriers
La Ciotat,  FR 13705
Correspondent Contact Kim Rouahi
Regulation Number872.1745
Classification Product Code
NBL  
Date Received11/17/2022
Decision Date 12/14/2023
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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