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510(k) Data Aggregation

    K Number
    K220330
    Device Name
    Soundly Anti Snoring Device
    Manufacturer
    Greystone IP Ltd
    Date Cleared
    2022-09-08

    (216 days)

    Product Code
    LRK, LOZ, LQZ
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Greystone IP Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Soundly Mandibular Advancement Device is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) whilst sleeping, in adults
    Device Description
    The Soundly Device is a mandibular advancement device to be worn by the patient in their own home at night whilst asleep. The advancement of the lower mandibular is an accepted method of reducing the incidence of light to moderate Obstructive Sleep Apnea (OSA). The Soundly Device consists of the following components: - . A single lower jaw splint that covers the lower teeth to the gum line. The lower splint has two wedge-shaped projections on its upper surface. These indentations are shaped to receive complementary wedges on the upper splint and so advance the lower jaw compared to the natural positioning. - . A set of three different upper jaw splints that cover the upper teeth to the gum line. Each upper jaw splint has a pair of wedges on its lower surface that interlock with the wedge indentation on the lower jaw. The set of three upper splints offer different amounts of mandibular advancement: They individually offer 40%, 60% or 70% of the maximum mandibular advancement that the patient's jaw can accommodate. The 70% value has an absolute maximum of 12 mm of mandibular advancement. The dental impressions of the lower and upper jaw and a bite registration of the patient at maximum comfortable mandibular advancement are made by the prescribing dentist. The impressions are sent to the Soundly labs for processing. The impressions are turned into plaster models in the usual method and then the plaster models are subject to 3D scanning to make electronic 3D models of the mandibular arches. The 3D models are processed in 3D design software into the set of splints, which are then 3D printed in a biocompatible photopolymer. The finished set of splints are returned to the prescribing dentist for final fitting on the patient.
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