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510(k) Data Aggregation
K Number
K222560Device Name
BlueCheck Caries Detection & Monitoring
Manufacturer
Incisive Technologies Pty Ltd
Date Cleared
2023-05-16
(265 days)
Product Code
LFC
Regulation Number
872.1740Why did this record match?
Applicant Name (Manufacturer) :
Incisive Technologies Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To aid the dental professional in the visualization of carious lesions.
Device Description
BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).
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