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510(k) Data Aggregation

    K Number
    K180691
    Device Name
    TrueDorsal Devices
    Manufacturer
    True Function Laboratory, Inc.
    Date Cleared
    2019-02-11

    (332 days)

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

    True Function Laboratory, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of TrueDorsal® Devices are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. TrueDorsal® Device is a prescription only device that is customized by True Function Laboratory to dentist specific instructions. It is inserted and removed by the patient and adjusted by the prescribing dentist.
    Device Description
    Not Found
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    K Number
    K170578
    Device Name
    True Function Adjustable Herbst Appliances
    Manufacturer
    True Function Laboratory, Inc.
    Date Cleared
    2017-11-24

    (270 days)

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

    True Function Laboratory, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance that is customized by True Function Laboratory to dentist specific instructions.
    Device Description
    TrueFunction® - Adjustable Herbst Appliances are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Material composition of the proposed devices include acrylic PMMA, dual laminate polymers, stainless steel ball clasps, exing elements and adjustment key and colorant. Also provided with the device is a stainless steel key used to make necessary mandibular protrusion adjustments by turning the screws as needed. They are available in three mandibular advancement models: The Dual Laminate, the Acrylic with Clasp, and the Acrylic without Clasp model. The Dual Laminate - this model has a soft, rubbery surface on the inside of each piece and a hard acrylic surface on the outside without metal clasps for retention. The appliance is held in place by the soft, rubbery liner. Patients must have adequate natural undercuts for retention of the Dual Laminate model, because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth. The Acrylic with Clasp and Acrylic without Clasp - the acrylic with clasp model has several metal ball clasps, which can be adjusted to increase retention on teeth that have insufficient undercuts. The ball clasps can often be modified, should further dental work be performed and adjustments required. For the non-clasp model, the patient must have adequate natural undercuts because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth. TrueFunction® - Adjustable Herbst Appliances mandible protrusion is controlled by stainless steel tubes & rods or screws for all three mandibular advancement designs. Each device is fabricated to the prescription of a dentist. TrueFunction® - Adjustable Herbst Appliances device components comes in contact with the patient's gum (please reference the diagram below), and are composed of Methyl Methacrylate, Thermoplastic Polyurethane and high grade Chromium-nickel steel.
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