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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEMREX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
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