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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
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K171729
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dreve Denatmid GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    1. A table of acceptance criteria and the reported device performance

    AttributeAcceptance Criteria (from predicate Fixtemp® C&B)Reported Device Performance (Fixtemp® C&B 4:1)
    Processing/Working Time≥ 45 sec≥ 45 sec
    Curing Time in the mouth≥ 2 - 3 min≈ 2 - 3 min
    Setting Time≥ 6 min≥ 6 min
    Flexural Strength> 60 MPa> 60 MPa
    Water Sorption≤ 40 µg/mm³≤ 40 µg/mm³
    DurationShort term
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