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510(k) Data Aggregation

    K Number
    K152451
    Device Name
    VINTAGE Art LF
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2015-12-11

    (105 days)

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

    VINTAGE Art LF

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

    Shade adjustment of Lithium disilicate and ceramic restorations

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA clearance letter for a dental device (porcelain powder) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It discusses the device's substantial equivalence to other legally marketed devices but does not detail performance metrics, study designs, or effectiveness. Therefore, I cannot extract the requested information from this document.

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