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510(k) Data Aggregation

    K Number
    K190583
    Device Name
    DynaFlex
    Manufacturer
    DynaFlex
    Date Cleared
    2019-06-27

    (113 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    DynaFlex

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaFlex® Clear Aligner is a series of clear, lightweight, plastic retainers indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state.
    Device Description
    DynaFlex ® Clear Aligner Appliance is a series of clear, lightweight, plastic retainers indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion in patients by moving teeth progressively to a final, treated state. The device will be patient-specific and will be sold by prescription. The device is manufactured with medical grade thermo plastic that is standard throughout the industry. Aligners are fabricated from .030 thermoformed plastic. The mechanism of force application to the teeth is via intentional distortion of the plastic as the aligners are seated in the mouth. Each subsequent aligner in the overall progressive series is made from a mold of the patient's teeth which reflect subtle changes in the teeth from the previous aligner. The positional changes are introduced into each aligner in the laboratory by moving the teeth on the construction model and then forming the aligner on the same model. The overall treatment is prescribed by the dentist to the laboratory where they are fabricated. Aligners may be adjusted by the dentist. Aligners are completely removable by the patient and treatment may be discontinued at any time. The appliance if provided as a non-sterile device and single use.
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    K Number
    K103076
    Device Name
    DYNAFLEX
    Manufacturer
    DYNAFLEX
    Date Cleared
    2011-02-23

    (128 days)

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

    DYNAFLEX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaFlex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.
    Device Description
    The proposed DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices used for treating snoring and sleep apnea, and will consist of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs, or by the industry standard Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These devices function as a mandibular re-positioner which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The devices will be custom made for each patient and have the ability of the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The devices will be sold by prescription only. The LISA Appliance is a one piece, non-adjustable design. The LISA II Appliance is a dynamic, adjustable design. The Dorsal Appliance is a two-piece design with separate upper and lower acrylic portions that when engaged posture the mandible into protrusive position via acrylic fins built in the lower acrylic portion. The adjustable Herbst Appliance is a one piece construction held together by two adjustment mechanisms on the buccal or outer are of the upper and lower appliance.
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