FDA 510(k)

BlueCheck Caries Detection & Monitoring

K-Number: K222560 · 2023-05-16

ApplicantIncisive Technologies Pty, Ltd.

Decision Date2023-05-16

Product CodeLFC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BlueCheck Caries Detection & Monitoring is a medical device manufactured by Incisive Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-16 under approval number K222560. The device is classified under product code LFC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BlueCheck Caries Detection & Monitoring?

BlueCheck Caries Detection & Monitoring is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Incisive Technologies Pty, Ltd.. The 510(k) number is K222560.

When was BlueCheck Caries Detection & Monitoring approved by the FDA?

BlueCheck Caries Detection & Monitoring received FDA 510(k) clearance on 2023-05-16, under approval number K222560.

What company makes BlueCheck Caries Detection & Monitoring?

BlueCheck Caries Detection & Monitoring is manufactured by Incisive Technologies Pty, Ltd..

What is the FDA product code for BlueCheck Caries Detection & Monitoring?

The FDA product code for BlueCheck Caries Detection & Monitoring is LFC.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.