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510(k) Data Aggregation

    K Number
    K042931
    Device Name
    TUF LINK SILICONE RELINER
    Manufacturer
    DENTATUS USA, LTD.
    Date Cleared
    2004-12-08

    (47 days)

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

    TUF LINK SILICONE RELINER

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

    TUF LiNK Silicone Reliner is applied to acrylic dentures for the purpose of providing a soft tissue-bearing surface to the denture for patient comfort.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device called "Tuf Link™ Resilient Silicone Reliner." It does not contain any information about acceptance criteria, device performance metrics, clinical studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a regulatory document stating that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It refers to general controls, regulations, and advises the manufacturer on their responsibilities for registration, labeling, and good manufacturing practices.

    Therefore, I cannot provide a response to your request based on the provided text, as the necessary information is not present.

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