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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 St.
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
Predetermined Change
Control Plan Authorized		 No
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