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510(k) Data Aggregation

    K Number
    K142371
    Device Name
    Luminesse PMMA
    Manufacturer
    TALLADIUM, INC.
    Date Cleared
    2015-04-24

    (242 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Luminesse PMMA

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

    The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.

    Device Description

    The Luminesse PMMA is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Luminesse PMMA" and its indications for use. It primarily discusses regulatory compliance and contact information. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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