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510(k) Data Aggregation

    K Number
    K141503
    Device Name
    DENALI 501CEMENT
    Manufacturer
    DENALI CORPORATION
    Date Cleared
    2014-11-10

    (157 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K132393,K971372,K053565
    Why did this record match?
    Device Name :

    DENALI 501CEMENT

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

    Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. For Use only by a Licensed Dentist. Rx Use Only.

    Device Description

    Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. Denali 501 contains polymerizable monomers that can set in either a light activated mode or set upon mixing Part A and Part B. When set the resin has a low solubility in water to act as a long term cement.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification summary from the FDA for a dental cement called "Denali 501 Cement." It discusses the device's substantial equivalence to predicate devices based on various characteristics, but it does not detail specific acceptance criteria or a study designed to evaluate them in the context of your request.

    Therefore, I cannot provide the requested table or the details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

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