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510(k) Data Aggregation

    K Number
    K253355
    Device Name
    Difiney Advanced Anti Snoring Device 4.0
    Manufacturer
    Fissiontech LLC
    Date Cleared
    2025-10-29

    (29 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K250482
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Difiney Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.

    Device Description

    The Difiney Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring.

    The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.

    AI/ML Overview

    N/A

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