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510(k) Data Aggregation

    K Number
    K070538
    Device Name
    XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2007-03-14

    (16 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K050386
    Why did this record match?
    Device Name :

    XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE

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

    XP BOND is indicated for

    1. Direct, Light-cured composite and compomer restorative.
    2. Indirect Restorations; Light-cured, resin cemented Veneers.
    3. Composite, ceramic and amalgam repairs.
    4. Cavity varnish for use with fresh amalgam.
    5. Direct, dual cure or self-cure composite restorations and core build-ups.
    6. Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers.
    7. Dual cured and self cured resin cemented Endodontic post cementation.
    8. Adhesive bonding of direct amalgam restoration.
    Device Description

    The XP BOND Dual Cure is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

    The document is a 510(k) summary for a dental adhesive named "XP BOND Dual Cure Universal Total Etch Adhesive." It details the device description, intended use, technological characteristics, and its substantial equivalence to a predicate device.

    Specifically, the document states:

    • "All of the components found in XP BOND have been used in legally marketed devices and were found safe for dental use."
    • "XPBOND has been evaluated and passed biocompatibility testing for Cytotoxicity, Ames Test."
    • "We believe that the prior use of the components of XP BOND in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of XP BOND for the indicated uses."

    This indicates that the safety and effectiveness determination for this dental adhesive is based on:

    1. Prior use of its components in legally marketed devices.
    2. Biocompatibility testing.
    3. General "performance data provided" (the specifics of which are not detailed in this summary).

    Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or other details related to a study for an AI/ML device. This document does not describe such a device or study.

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