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510(k) Data Aggregation

    K Number
    K233844
    Device Name
    OdneClean
    Manufacturer
    Odne AG
    Date Cleared
    2024-08-08

    (248 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K143448,K093000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Odne AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    OdneClean is intended to prepare, clean, and irrigate teeth indicated for root canal therapy.

    Device Description

    OdneClean is a dental device for the preparation of root canals during endodontic procedures. It achieves this by the creation of hydraulic cavitation inside the root canal. It consists of a console (control unit), an irrigation fluid reservor (saline solution bag or bottle), and a handpiece that is equipped with single-use OdneClean tips.

    OdneClean delivers a stream of pressurized irrigation fluid (0.9 % NaCl) into the root canal. Upon leaving the narrow nozzle of the tip, it creates hydraulic cavitation inside the fluid stream, which enables the removal of organic matter from the root canal.

    OdneClean features a user interface on its console and an on/off button on the handpiece. It provides automatic priming and disinfection programs to prepare the device for use and disinfect the internal fluid path after use. A waste container collects the fluid generated during priming and disinfection.

    OdneClean is used after a conventional access cavity preparation, determination of the working length, and minimal shaping of the root canal. Following OdneClean treatment, root canals are to be disinfected using standard procedures.

    AI/ML Overview

    I am sorry, but the provided text does not contain the specific details required to fulfill your request regarding acceptance criteria and study information for the OdneClean device. The text primarily focuses on regulatory approval (510(k) clearance) and general statements about compliance with standards and successful benchtop testing. It does not provide:

    • A table of specific acceptance criteria and reported device performance values.
    • Sample sizes for test sets, data provenance, or details on ground truth establishment.
    • Information on expert qualifications or adjudication methods.
    • Details on MRMC studies, effect sizes, or standalone algorithm performance.
    • Training set details.

    Therefore, I cannot generate the requested JSON output.

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