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510(k) Data Aggregation

    K Number
    K963078
    Device Name
    STERI-OSS TEMPORARY IMPLANT CEMENT
    Manufacturer
    STERI-OSS, INC.
    Date Cleared
    1996-09-10

    (33 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

    The cement is indicated for use in the cementing (luting) of a implant prosthesis.

    Device Description

    The Steri-Oss Temporary Implant Cement serves as a cement for retention of implant prosthesis. The cement is a two part paste which is self cured on mixing and application. The product is provided in two 10 gram containers of polyalkylene material.

    AI/ML Overview

    This document is a 510(k) summary for a dental cement. It does not contain any information about acceptance criteria or a study proving device performance against such criteria for AI/ML device.

    The document states: "Performance Data... Not applicable, 510(k) requests a indication." This indicates that for this particular type of medical device (a dental cement), the submission requirements at the time did not necessitate extensive performance data beyond demonstrating substantial equivalence to a predicate device for its intended use.

    Therefore, I cannot provide the requested information.

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