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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light-Induced Fluorescence Caries Detector
510(k) Number K231722
Device Name SmarTooth
Applicant
Smartooth Co., Ltd.
509, 10, Noryangjin-Ro, Dongjak-Gu
Seoul,  KR 06938
Applicant Contact Seohyun Yoon
Correspondent
Lighten Bridge, LLC
4408 Tortuga Ln.
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number872.1745
Classification Product Code
NBL  
Date Received06/13/2023
Decision Date 05/01/2024
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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