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510(k) Data Aggregation

    K Number
    K991974
    Device Name
    FUTURA GLASS IONOMER SILVER REINFORCED
    Manufacturer
    AB ARDENT
    Date Cleared
    1999-09-17

    (98 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FUTURA GLASS IONOMER SILVER REINFORCED

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

    FUTURA GLASS IONOMER SILVER REINFORCED RESTORATIVE is to be used as a base, lining and filling material for restoring function to teeth which have lost portions to caries:

    • Class I and II cavities in deciduous teeth.
    • Repair of amalgam restored teeth (fractured restoration or tooth).
    • Class I and II cavities in selected permanent teeth.
    • Lining under amalgam or posterior composite restorations.
    • Cavities where radiopacity is a prime requirement.
    • Core build up material under crowns.
    • On root surface for locating overdentures.
    • Long term temporary replacement of cusps
    • Repairs to crown margins.
    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for a dental restorative material (Futura Glass Ionomer Silver Reinforced Restorative), indicating that the device is substantially equivalent to a legally marketed predicate device.

    The information you've requested typically involves performance data, study designs, sample sizes, and expert qualifications, which are not detailed in this regulatory clearance letter. This letter primarily confirms that the device can be legally marketed based on its equivalence to existing products, rather than providing a comprehensive report on its clinical performance and the studies used to establish specific performance criteria.

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