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510(k) Data Aggregation

    K Number
    K191320
    Device Name
    Slow Wave DS8
    Manufacturer
    Slow Wave, Inc.
    Date Cleared
    2020-10-02

    (506 days)

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

    Slow Wave, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
    Device Description
    DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured at Slow Wave facilities using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material. The trays are designed to be an exact custom fit by a trained dental technician, using a 3Shape intraoral scanning device, or comparable intraoral scanner such as the iTero, or Cerec, registering one's full impressions of the upper teeth, lower teeth. A bite scan registration with a gap (typically 8 mm), which is a crucial design feature. The gap results from the design of the lower and upper trays. The upper and lower trays, the molars, premolars, and canines, are covered by the device. However, the lateral or central incisors are not covered, which effectively leaves eight teeth (four maxillary incisors and four mandibular incisors) uncovered. The trays are shaped like arch because the covered portion of the device is connected to each other by two palatal bands one connecting the upper left and upper tray, and the other connecting the lower tray. Additionally, the trays are built with ramps that guide the mandible forward and downward, thus maintaining advancement, enlarging the airway, allowing more room for the tongue to migrate forward naturally. The vertical opening of the jaw is not fixed in a single position. DS8 is a traction-based mandibular repositioning device that allows nasal and/or oral breathing.
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