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510(k) Data Aggregation

    K Number
    K970775
    Device Name
    TEMPO CEM (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1997-06-03

    (91 days)

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

    TEMPO CEM (MULTIPLE)

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

    TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Foremost Dental Mfg, Incorporated regarding their device, TempoCem. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.

    However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

    The document primarily focuses on:

    • The FDA's determination of substantial equivalence.
    • Regulatory classification of the device (Class II).
    • General controls provisions of the Act that apply to the device.
    • Instructions for the manufacturer regarding labeling and promotion inquiries.
    • Indications for use for TempoCem (temporary cementation of provisional crowns and bridges).

    Therefore, I cannot provide the requested information as it is not present in the given text.

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