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510(k) Data Aggregation

    K Number
    K181496
    Device Name
    VINTAGE PRO
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2018-12-18

    (194 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 PRO

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

    Build-up porcelain for fabrication of metal bonded ceramic restorations

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is an FDA 510(k) clearance letter for a dental product called "Vintage Pro." It describes the regulatory classification, product code, and indications for use of this porcelain powder for clinical use.

    This document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to an AI/device performance evaluation. Therefore, I cannot extract the requested information to fill in your table and answer your questions.

    To help you, I would need a document that describes the clinical performance study of a device, particularly an AI-powered one, detailing its validation process.

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