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510(k) Data Aggregation

    K Number
    K040895
    Device Name
    INTEGRITY TEMPORARY CEMENT
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2004-05-21

    (45 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K853431,K854253
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    INTEGRITY™ TEMPORARY CFMENT is indicated for: 1) temporary cementation of provisional acrylic and composite indirect restorations to prepared teeth or implant abutments; 2) provisional or trial cementation of ccramic, porcelain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to prepared tecth or implant abutments; and 3) ccmentation of ceramic, porcclain, composite, PFM (porcelain fused to metal) and all metal crowns and bridges to implant abutments and telescopic fixed restorations which require periodic removal for maintenance, etc.

    Device Description

    INTEGRITY™ TEMPORARY CEMENT is a dual-cured or selfcured temporary resin cement for use with provisional crown and bridge restorations. The cement is dispensed from a dual barrel 5 ml syringe for hand-mixing on a mix pad or for use with an automix tip. It is then polymerized by dual curing. Visible light initiators are used for self-curing.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental cement called "INTEGRITY™ TEMPORARY CEMENT." It describes the device, its intended use, and technological characteristics, and states its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details typically found in performance studies for AI/ML devices.

    Therefore, I cannot provide the requested information in the structured table and points as the document does not contain this type of data. The document focuses on establishing substantial equivalence for a physical medical device (dental cement) based on its components, biocompatibility, and intended use, rather than on a software or AI/ML device that would require performance metric studies.

    The closest relevant statements are:

    • "INTEGRITY™ TEMPORARY CEMENT has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, mutagenicity, irritation and sensitization."
    • "We believe that the prior use of the components of INTEGRITY™ TEMPORARY CEMENT in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of INTEGRITY™ TEMPORARY CEMENT for the indicated uses."

    These statements refer to "performance data" and "biocompatibility testing," but do not provide details on specific acceptance criteria, reported performance values, study designs, sample sizes, ground truth establishment, or expert involvement as requested for an AI/ML device.

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