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510(k) Data Aggregation

    K Number
    K993124
    Device Name
    DISPODRILL
    Manufacturer
    KIS PRODUCTS
    Date Cleared
    2001-08-06

    (686 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DISPODRILL

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

    Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity Cutting and preparation of tooth stracture, ooth onainer and/or abrasion of tooth surfaces and dental restorations to enhance adhesive restorative procedures.

    Indications for use are identical to PrepStar™ by Danville Engineering Inc.

    For Use by Dentists Only.

    Device Description

    Disposable Dental Air Abrasion Handpiece

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to KIS Products, Inc. regarding their Disposable Dental Air Abrasion Handpiece. It states that the device is substantially equivalent to legally marketed predicate devices.

    The letter does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

    Therefore, I cannot provide the requested information. The document is solely an FDA clearance letter based on substantial equivalence, not a detailed report of performance testing or clinical studies with acceptance criteria.

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