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510(k) Data Aggregation

    K Number
    K250353
    Manufacturer
    Date Cleared
    2025-09-04

    (209 days)

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

    Oniris and Oniris Plus devices are indicated for use on adult patients 18 years of age or older as an aid for the reduction of snoring (OTC).

    Oniris Plus device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults. (Rx)

    Device Description

    The Oniris and Oniris Plus devices are intraoral mandibular advancement appliances. Each device consists of two independent splints, over-molded with a thermoforming material, ensuring a customized fit for the user. One splint is designed for the maxillary arch (labeled "Up") and the other for the mandibular arch (labeled "Down"). The splints are custom-fitted by the end user at home using a simple "Boil-and-Bite" process, eliminating the need for professional dental impressions.

    The two splints are connected via advancement hooks, which allow for mandibular protrusion adjustments. Oniris and Oniris Plus OTC devices offer 5 sizes of advancement hooks, while Oniris Plus Rx device provides 10 sizes, enabling precise customization of the mandibular advancement. These hooks maintain the mandible in a forward position, optimizing airflow and reducing air turbulence, a key factor in snoring and airway obstruction. Users can adjust the device for up to 6 mm (OTC) and 11 mm (Rx) of mandibular advancement by interchanging the hooks to achieve the most effective and comfortable setting.

    As predicate devices, Oniris and Oniris Plus feature an independent bi-bloc design, allowing for vertical articulation. This enhances patient comfort and ensures a more natural fit.

    AI/ML Overview

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