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510(k) Data Aggregation

    K Number
    K014249
    Device Name
    JETPOLISHER
    Manufacturer
    DELDENT LTD.
    Date Cleared
    2002-02-19

    (55 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The JETPOLISHER airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device called "JetPolisher." It primarily concerns the regulatory approval process and does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory compliance requirements.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as they are not present in the provided text.

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