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510(k) Data Aggregation

    K Number
    K984340
    Device Name
    STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
    Manufacturer
    STERNGOLD/IMPLAMED
    Date Cleared
    1999-01-08

    (35 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K970774
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.

    Device Description

    The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.

    AI/ML Overview

    The Sterngold ImplaMed Abbreviated 510(k) Premarket Notification for the SternOmega Temporary Cement Automix NE does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

    The document explicitly states:

    "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Temporary Cement Automix NE are equivalent to those of the predicate device."

    Therefore, I cannot provide a response to your numbered points as the requested information is absent from the provided text. The submission relies solely on demonstrating substantial equivalence to a predicate device (TempoCem NE) based on design and material characteristics, rather than presenting new performance or safety study data.

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