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510(k) Data Aggregation

    K Number
    K040315
    Device Name
    MYOHEALTH CLENCHING INHIBITOR
    Manufacturer
    MCI-MYOHEALTH SYSTEMS
    Date Cleared
    2004-08-27

    (200 days)

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

    MCI-MYOHEALTH SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Protection of teeth and restorations from the forces of bruxism. 2. For the prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity.
    Device Description
    The Myohealth Clenching Inhibitor disrupts the activity of the perieranial musculature by providing contact between the ental contact provided by this intraoral device modifies the rearward tectir. The mounted contraction of the pericranial musculature and the associated bruxism and temporal mandibular disorders. The MCI is an anterior device custom fabricated for each patient. The Myohealth The MCI Is an amerior dories do for treating conditions diagnosed by medical professionals. The MCI Clenching Inhibitor is designed to span 6 teeth, from upper cuspid to cuspid. The larger size of the MCI greatly reduces the risk of inhalation or swallowing this appliance. The MCI Clenching Inhibitor has a thermoplastic lining. This lining ensures excellent long term retention.
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