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    K Number
    K241226
    Device Name
    Fixtemp® C&B 4:1
    Manufacturer
    Dreve Denatmid GmbH
    Date Cleared
    2024-05-31

    (29 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dreve Denatmid GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixtemp® C&B 4:1 is a resin-based material used to fabricate temporary crowns and bridges.
    Device Description
    Fixtemp® C&B 4:1 is an automatically mixable self-curing composite, used for the direct and indirect fabrication of temporary crowns and bridges. Fixtemp C&B 4:1 is a Type 1 – polymer-based material, per ISO 10477:2020. It is available in the tooth colors A1, A2, A3, A3.5, B1 and Bleach X.
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