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510(k) Data Aggregation

    K Number
    K982590
    Device Name
    TEMPBOND CLEAR-2
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1998-10-08

    (76 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TEMPBOND CLEAR-2

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

    TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.

    Device Description

    The device is a dual cured, self-cured and visible light-cured, resin-based cement designed to be used in conjunction with temporary crowns, bridges, inlays and onlays. The highly translucent nature of TempBond Clear - 2 provides a pleasing, tooth-like appearance even when margins are exposed.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental cement called "TempBond Clear - 2", which includes general device information, its intended use, and substantial equivalence claim to another legally marketed device. It also includes an FDA letter confirming the device's substantial equivalence and allowing it to be marketed.

    Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the given text.

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