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510(k) Data Aggregation

    K Number
    K123273
    Device Name
    HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
    Manufacturer
    TEMREX CORP.
    Date Cleared
    2012-12-07

    (49 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indications For Use: Hoffmann's cements (Phosphate- Normal, quick setting) is indicated for the temporary application of provisional crowns, bridges, inlay, and onlays. Luting/ lining cements.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental cement called "Hoffmann's Cement." It does not contain information about the acceptance criteria or a study that proves a device meets those criteria.

    Therefore, I cannot provide the requested information. The document is strictly a regulatory approval notice for a medical device.

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