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510(k) Data Aggregation

    K Number
    K062333
    Device Name
    LAIMAD
    Manufacturer
    STEVEN LAMBERG, D.D.S
    Date Cleared
    2006-12-14

    (126 days)

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

    STEVEN LAMBERG, D.D.S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lamberg Sleep Well device is intended to reduce night time snoring. The Lamberg Sleep Well device is indicated for use in adults 18 years of age or older in a home or sleep laboratory environment. The device must be prescribed by a dentist or physician.
    Device Description
    The Lamberg Sleep Well device is a one piece, custom-molded device that advances the mandible by 5 mm. The body of the device extends over the upper incisors, and is 2 – 3 mm thick. A central protrusive element hangs down to contact the lingual lower incisors. An Adams clasp is placed to hold the device securely to each of the upper first molars. The appliance ends at the distal of the first molars on the palate.
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