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510(k) Data Aggregation

    K Number
    K102223
    Device Name
    CHALLENGE-EVER
    Manufacturer
    HALLIM DENTECH CO., LTD.
    Date Cleared
    2011-02-25

    (203 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CHALLENGE-EVER is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental operative unit and accessories (CHALLENGE-EVER / HL-2060, HL-2060A). It primarily pertains to regulatory approval based on substantial equivalence to predicate devices. This type of document does not contain the detailed information required to answer questions about acceptance criteria, study designs, sample sizes, ground truth establishment, or human reader performance from a clinical trial.

    Therefore, I cannot extract the requested information from this document. The letter only establishes that the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." It does not describe performance acceptance criteria or the specific study that proves the device meets such criteria.

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