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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K222560
Device Name BlueCheck™ Caries Detection & Monitoring
Applicant
Incisive Technologies Pty Ltd
Level 4, 71 Collins Street
Melbourne,  AU 3000
Applicant Contact Kerry A Hegarty
Correspondent
PaxMed International, LLC
12264 EL Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number872.1740
Classification Product Code
LFC  
Date Received08/24/2022
Decision Date 05/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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