BlueCheck Caries Detection & Monitoring— 510(k) K222560

Name: FDA 510(k) clearance K222560
Creator: U.S. Food and Drug Administration
Published: 2023-05-16

Substantially Equivalent

Incisive Technologies Pty, Ltd.

FDA 510(k) clearance K222560 for BlueCheck Caries Detection & Monitoring, Substantially Equivalent on 2023-05-16. Applicant: Incisive Technologies Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Incisive Technologies Pty, Ltd.
Product code: Code LFC
Device class: Class 2
Regulation: 21 CFR 872.1740
Advisory panel: Dental
Date received: 2022-08-24
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.