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510(k) Data Aggregation

    K Number
    K981448
    Device Name
    KERR HARD DENTURE RELINE MATERIAL
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1998-06-16

    (55 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of Kerr Hard Denture Reline Material is for the restoration of function and form in dentures which have become ill-fitting due to alveolar bone loss over a period of time.

    Device Description

    The device is a paste/paste methacrylate based system for restoring function, comfort and esthetics to ill-fitting dentures. The system can be used either in the dental office or in the dental laboratory for relining of dentures.

    AI/ML Overview

    The provided document is a 510(k) Summary for a dental device (Kerr Hard Denture Reline Material) and an FDA clearance letter. It does not describe a study involving an AI model or a device that uses AI. Therefore, I cannot extract information about acceptance criteria, study details, expert involvement, or AI performance metrics as requested.

    The document discusses the substantial equivalence of the Kerr Hard Denture Reline Material to a legally marketed predicate device (Kooliner, GC America) based on similar function and intended use. This is a common regulatory pathway for medical devices that are not "AI-based."

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