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510(k) Data Aggregation

    K Number
    K152392
    Device Name
    VINTAGE LD
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2016-01-08

    (137 days)

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

    VINTAGE LD

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

    Build up porcelain for fabrication of all ceramic restorations including lithium disilicate

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental porcelain powder product (VINTAGE LD). It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    The document is purely an administrative letter stating that the FDA has reviewed the submission and determined substantial equivalence to legally marketed predicate devices, allowing the manufacturer to market the device. It also includes the "Indications for Use" for the VINTAGE LD product, stating it is a "Build up porcelain for fabrication of all ceramic restorations including lithium disilicate."

    Therefore, I cannot provide the requested table and study details based on the given text.

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