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510(k) Data Aggregation

    K Number
    K093446
    Device Name
    VITA VMK MASTER
    Date Cleared
    2009-12-03

    (28 days)

    Product Code
    Regulation Number
    872.6660
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITA VMK MASTER

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

    Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) K093446 for "Vita VMK Master®" does not contain information about acceptance criteria, device performance metrics, or details of a study that would prove the device meets such criteria.

    The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, such as compliance with FDA regulations, registration, labeling, and adverse event reporting.

    The "Indications for Use" section simply describes the intended purpose of the device as a ceramic veneering material for a metal substructure in dental restorations, to be used by a dental professional.

    Therefore, I cannot provide the requested information based on the given input.

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