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510(k) Data Aggregation

    K Number
    K993475

    Validate with FDA (Live)

    Device Name
    AUROFLUID M, ALLOY NO. 5315
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1999-12-09

    (56 days)

    Product Code
    EJS
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K024143
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Fabrication of Dental Crowns, Bridges, Inlays and Cast Partial-denture Frames.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a dental material called "Aurofluid M." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to existing devices, not on performance studies or acceptance criteria for a new device's performance.

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