Class Class II
BlueCheck™ Caries Detection & Monitoring (K222560)
Description
BlueCheck™ Caries Detection & Monitoring by Incisive Technologies Pty, Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222560
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeLFC
Regulation Number872.1740
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222560
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BlueCheck™ Caries Detection & Monitoring (K222560) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200601 | LumiCare Caries Diagnostic Rinse | GreenMark Biomedical, Inc. | 2021 |
Trace the full predicate network for K222560
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.