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510(k) Data Aggregation

    K Number
    K964867
    Device Name
    HYBRID RESIN COMPOSITE
    Manufacturer
    PARKELL, INC.
    Date Cleared
    1997-04-11

    (127 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K851897,K863951,K871587,K872702,K882352,K910103,K930193,K932845,K940027
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth. The above-cited material contains materials that are common in dental ine above of consard consard when used according to directions. Use resind and poss no may be contra-indicated in persons with known acrylate allergies and/or hypersensitivities. The material is polymerizable with currently available visible light curing devices.

    Device Description

    May be described as a radiopaque, light-cured, hybrid composite resin for use as a tooth colored dental restorative in Class I, II, III, IV and V cavities. It is contoured and polished using currently available finishing diamonds, finishing burs, discs, and polishing pastes. When used as indicated, the material is recommended for restoring proper form and function of restored teeth. The above-cited material contains materials that are common in dental ine above of consard consard when used according to directions. Use resind and poss no may be contra-indicated in persons with known acrylate allergies and/or hypersensitivities. The material is polymerizable with currently available visible light curing devices.

    AI/ML Overview

    This 510(k) premarket notification for Parkell's Hybrid Composite Resin is for a dental restorative material, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment (which are all relevant to AI/ML device validation) is not included in this document.

    The provided text describes a traditional medical device (dental composite resin) and focuses on its chemical composition, intended use, and equivalence to existing products. It does not involve any algorithms, AI, or machine learning that would necessitate the type of performance evaluation outlined in your request.

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