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510(k) Data Aggregation

    K Number
    K212939
    Device Name
    Vintage Prime Press
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2022-03-18

    (184 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 Prime Press

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

    Fabrication of all ceramic restorations except for four- or more unit bridges including molars.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a dental product called "Vintage Prime Press," which is a porcelain powder for clinical use. It outlines the regulatory clearance process and the indications for use of this device.

    The document does not describe acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria. It discusses the regulatory path, product classification, and general controls applicable to the device.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, information about sample sizes or data provenance for a test set, details on expert roles for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

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