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510(k) Data Aggregation

    K Number
    K013808
    Device Name
    SLEEPBITE
    Date Cleared
    2002-01-30

    (76 days)

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

    DENTAL IMAGINEERS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SleepBite is prescribed for the patient by the healthcare professional. - A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea. - B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed Steep Bite is indicated for ass in for obstructive sleep apnea. - C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.
    Device Description
    SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. The screw is located on the anterior segment of the lower plate and extends slightly between the lips. A small adjustment wrench is used to turn the screw, and thereby, it allows the mandible to be anteriorized relative to the maxilla. The clinician can determine the magnitude of the advancement via a calibrated scale which part of the screw itself. The scale is marked in 2mm units. The connectors between the upper and lower plates are flexible elastomeric tubes that have the ability to remain sufficiently rigid to college the mandible to open have the ability to remain surficiently right of personalisms the mandible to open while they also allow complet lateral monomia in use and of thin ethylene vinyl sufficiently to permit oral breathing. The dentil not riminge on freeway space. sufficiently to permit oral breathing. The demal places our of market the way space.
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    K Number
    K991449
    Device Name
    SNORE-AID PLUS
    Date Cleared
    1999-07-22

    (87 days)

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

    DENTAL IMAGINEERS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Snore-Aid®plus is a perscribed anti-snoring device. Snore-Aid®plus is indicated for use in patients with primary snoring A. or snoring and mild OSA (obstructive sleep apnea) where mandibular advancement and elevation of the tongue can increase a patient' s pharyngeal air space. Snore-Aid®ø/us is indicated to prevent symptoms of nocturnal B. parafunctional jaw activity in patients undergoing treatment for snoring and OSA by mandibular advancement and tongue positioning.
    Device Description
    Snore-Aid@plus is a single plate mandibular advancement and tongue positioning orthotic consisting of: (1) a flat mandibular occlusal bite plate, (2) an adjustable external maxillary lip shield, and (3) a wide occlusal surface. The occlusal bite plate provides dental stability, protects the TMJ from occlusal loading and prevents muscle soreness due It also actively elevates and positions the tongue anteriorly to bruxism. and dorsally against the palate, thereby increasing the patency of the airway.
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