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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 the device name listed in this FDA 510(k) record. The listed applicant is Incisive Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-16 under 510(k) 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. The listed applicant is Incisive Technologies Pty, Ltd.. The 510(k) number is K222560.

When did BlueCheck™ Caries Detection & Monitoring receive FDA 510(k) clearance?

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

Who is the listed applicant for BlueCheck™ Caries Detection & Monitoring?

The FDA 510(k) record lists Incisive Technologies Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: LFC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200601LumiCare Caries Diagnostic RinseGreenMark Biomedical, Inc.K193447Vista DyesInter-Med/Vista Dental Products

Official Source

View on FDA Database →

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

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