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510(k) Data Aggregation

    K Number
    K241056
    Date Cleared
    2024-07-16

    (89 days)

    Product Code
    Regulation Number
    872.3200
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:

    • Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
    • Repair of dental restorations of ceramic, composites and/or metal alloys;
    • Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "Light Cure Adhesive" device, which is a dental bonding agent. It discusses regulatory matters, such as substantial equivalence, general controls, and good manufacturing practices.

    It does not include details about:

    • Acceptance criteria table and reported device performance for a study proving the device meets the criteria.
    • Sample sizes or data provenance for a test set.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Training set sample size or how its ground truth was established.

    This document is a regulatory approval, not a clinical or performance study report for an AI/software-based medical device. Therefore, I cannot extract the requested information from the given text.

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