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510(k) Data Aggregation

    K Number
    K043119

    Validate with FDA (Live)

    Device Name
    AMELOGEN PLUS
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    2004-12-17

    (37 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Special
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K052189,K201795
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidy] methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental resin material named "Amelogen Plus." It confirms the device's substantial equivalence to a predicate device but does not detail any performance study, acceptance criteria, or related metadata.

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