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510(k) Data Aggregation

    K Number
    K972965
    Device Name
    STERI-OSS UNTIL IMPLANT CEMENT
    Manufacturer
    STERI-OSS, INC.
    Date Cleared
    1997-11-07

    (88 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STERI-OSS UNTIL IMPLANT CEMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The cement is indicated for use in the cementing (luting) of a implant prosthesis.
    Steri-Oss Until . Implant Cement is indicated_ for .... cementing (luting) of a implant prosthesis.

    Device Description

    The Steri-Oss Until Implant Cement serves as a cement for retention of armund on mixing cement serves as a cement roll - that is self cured on mixing The cement is a cwo pars pars provided in two 10 gram containers of polyalkylene material.

    AI/ML Overview

    The provided text is a 510(k) submission for the Steri-Oss Until Implant Cement. It details the device's description, intended use, and comparison to a predicate device for substantial equivalence. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

    Therefore, I cannot provide the requested information from the given input. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting performance data against predefined acceptance criteria from a specific study.

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