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510(k) Data Aggregation

    K Number
    K162816
    Device Name
    SML-OSA2 Appliances
    Manufacturer
    SELANE PRODUCTS, INC.
    Date Cleared
    2017-07-27

    (294 days)

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

    SELANE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SML OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
    Device Description
    The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force. The SML-OSA2 Appliances are customized, intraoral dental devices designed to reduce snoring and mild to moderate obstructive sleep apnea in adults. The devices fit over the dentition and reposition the mandible in a slightly protrusive position. The SML-OSA2 APPLIANCES consist of 2 arch forms that are linked to advance the mandible, and are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
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    K Number
    K130130
    Device Name
    ATG/SM-OSA APPLIANCES
    Manufacturer
    SELANE PRODUCTS, INC.
    Date Cleared
    2013-08-26

    (221 days)

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

    SELANE PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
    Device Description
    The ATG/SM-OSA APPLIANCES are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Three designs are included: Adjustable Herbst, Adjustable Dorsal, and MIRS. The mandible protrusion is controlled by stainless steel tubes & rods or screws for the Herbst and Dorsal designs. The MIRS single-piece construction has a lingual rest to set the mandibular protrusion. Each device is fabricated to the prescription of a dentist.
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