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510(k) Data Aggregation

    K Number
    K972683
    Device Name
    V-DELTA 450
    Manufacturer
    METALOR DENTAL USA CORP.
    Date Cleared
    1997-08-18

    (32 days)

    Product Code
    EJS
    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

    For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) premarket notification letter from the FDA regarding a dental device called "V-Delta 450" and its indications for use. This type of document does not contain information about acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information. The documents primarily confirm the substantial equivalence of the device to a predicate device and approve its marketing, outlining regulatory compliance requirements.

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