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510(k) Data Aggregation

    K Number
    K230548
    Device Name
    Myoaligner Appliance
    Manufacturer
    Myohealth Technologies, LLC
    Date Cleared
    2024-02-02

    (339 days)

    Product Code
    MQC, OCO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Myohealth Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For protection against teeth grinding, and jaw clenching; protections from injury due to bruxism or clenching; relief of bruxism related headaches, migraines and pain; short-term relief from muscle spasm due to occlusal interference; prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscles; and temporary treatment of temporal mandibular disorder (TMD) along with the relief of associated headaches and pains in adults 18 years of age or older.
    Device Description
    The Myoaligner appliance is a customized, removable dental device which is designed to overlay the existing dentition without the need for any alterations done to the receiving dentition. The appliance is a plural piece intra-oral removable appliance, which is designed and delivered to the patients by a licensed practitioner such as a dentist (Rx only). The dentist can prescribe a device that fits over the 4-6 front teeth, back teeth on both sides of the dental arch or all of the teeth in the dental arch both on the upper or lower jaw. The appliance is held in place by mechanical retention. The Myoaligner appliance can be worn on either the top or bottom teeth or both. It is intended for use in adults 18 years of age and older.
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