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510(k) Data Aggregation

    K Number
    K163580
    Device Name
    ASD Oral Appliances
    Manufacturer
    AMERICAN SLEEP DENTISTRY
    Date Cleared
    2017-06-08

    (170 days)

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

    AMERICAN SLEEP DENTISTRY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.
    Device Description
    The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy. The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.
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