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510(k) Data Aggregation

    K Number
    K982606

    Validate with FDA (Live)

    Device Name
    AUROFLUID CPF
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1998-10-15

    (80 days)

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

    For Use in the Fabrication of Dental Crowns, Bridges, Inlays and Onlays.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental product called "Aurofluid CPF". This document primarily focuses on regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given text.

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