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510(k) Data Aggregation

    K Number
    K101493
    Device Name
    ADVANCED GLASS IONOMER (K-130) RESTORATIVE
    Manufacturer
    DENTSPLY INTERNATIONAL, INC.
    Date Cleared
    2010-08-19

    (79 days)

    Product Code
    EMA,EBC,EBF,EJK
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K960954
    Why did this record match?
    Reference Devices :

    K960954

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

    Advanced Glass Ionomer (K-130) Restorative Material is indicated for semi-permanent restorations of class I and II cavities in posterior teeth; Restoration of deciduous teeth; Restoration of Class V lesions and cavities; Restoration of Class III cavities; Base/ Core-buildup. When used as a core-build-up, 2/3 of the remaining coronal dentine or at least 2mm of circumferential coronal dentine should be left for retention.

    Device Description

    Advanced Glass Ionomer (K-130) is a fast-setting, high viscosity radiopaque chemical curing glass ionomer restorative material. The restorative is available in 5 shades and comes in mixing capsules for direct application.

    AI/ML Overview

    The provided text describes a 510(k) submission for a dental restorative material, not an AI/ML powered medical device. Therefore, the information requested in the prompt (acceptance criteria and study details for an AI-powered device) is not present in the document.

    The document discusses:

    • Device Name: Advanced Glass Ionomer (K-130) Restorative
    • Submitter: DENTSPLY International
    • Predicate Device: 3M Ketac-Molar Aplicap (K960954)
    • Description: Fast-setting, high viscosity, radiopaque chemical curing glass ionomer restorative material.
    • Indications for Use: Semi-permanent restorations, restoration of deciduous teeth, Class V and III lesions, base/core-buildup.
    • Non-Clinical Performance Data: Cytotoxicity test, chemical analyses of leachable compounds, and in-vitro bench tests demonstrating compliance with ISO-9917:2007 (Dentistry: Water based cement, Part I, Powder/Liquid acid-base cements).
    • Conclusion: The device is considered substantially equivalent to its predicate based on technological characteristics and performance/biocompatibility data.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this document pertains to a dental material.

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