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510(k) Data Aggregation

    K Number
    K980568
    Device Name
    JUMBO GLASS IONOMER CEMENT
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    1998-04-30

    (80 days)

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

    JUMBO GLASS IONOMER CEMENT

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

    For cementing CR ENDOdontic posts, OR orthodoutics Ensociation ports, and be used as A. Filling or core buildup material, filling or correst, first

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental cement product. It confirms the device's substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for the specific information regarding a study proving the device meets acceptance criteria. The letter primarily focuses on regulatory approval and compliance.

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