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510(k) Data Aggregation

    K Number
    K143212
    Device Name
    Bifix Temp
    Manufacturer
    VOCO GMBH
    Date Cleared
    2015-05-01

    (172 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

    Bifix Temp is intended for use as:

    • Non-permanent luting of temporary restorations.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a letter from the FDA regarding a 510(k) premarket notification for a dental cement product, Bifix Temp. It primarily discusses the substantial equivalence determination and regulatory requirements, not performance studies or acceptance criteria.

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