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    K Number
    K090391
    Device Name
    PULPDENT MICRO-HYBRID COMPOSITE
    Manufacturer
    PULPDENT CORPORATION
    Date Cleared
    2009-05-11

    (83 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite used for esthetic, direct resin restorations including all cavity classifications (1-V),) anterior and posterior restorations, Class V restorations and direct veneering.

    Device Description

    Pulpdent Micro-Hybrid Composite is a radiopaque, light-cured, fine-particle hybrid dental composite for esthetic, direct resin restorations.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a dental composite material, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert adjudication, or MRMC studies.

    The document focuses on demonstrating substantial equivalence of the Pulpdent Micro-Hybrid Composite to existing predicate devices based on design, composition, performance, intended use, safety, and effectiveness, as per 21 CFR Part 872.3690. The safety and effectiveness are supported by general usage over 20 years for similar materials.

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