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510(k) Data Aggregation

    K Number
    K974772
    Device Name
    UFI GEL C
    Manufacturer
    VOCO GMBH
    Date Cleared
    1998-02-10

    (50 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UFI GEL C

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

    Ufi Gel C is intended for use as a permanently soft relining for total and partial dentures.

    • to relieve pressure from pressure spots
    • to dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
    • to cushion sharp-edged alveolar processes
    • to support the healing process in implantology
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "UFI Gel C." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

    The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to a predicate device marketed before May 28, 1976. It outlines the general controls and potential additional controls applicable to the device.

    Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets them, as this information is not present in the provided document. The request specifically asks for details relevant to AI/ML device studies (e.g., sample sizes, ground truth, experts, MRMC studies, standalone performance), none of which are mentioned here.

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