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510(k) Data Aggregation

    K Number
    K993507
    Device Name
    V-SUPRAGOLD, ALLOY NO. 5024
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1999-12-06

    (52 days)

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

    Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "V-Supragold." It confirms substantial equivalence and allows the marketing of the device.

    This document does not contain information about:

    • Acceptance criteria and reported device performance in a numerical table.
    • Details of a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics).

    Therefore, I cannot fulfill your request for this specific information based on the text provided.

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