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510(k) Data Aggregation

    K Number
    K043373
    Device Name
    DOLOTENS DENTAL TM 1
    Manufacturer
    NEUROMUSCULAR TECHNOLOGIES, INC.
    Date Cleared
    2005-09-02

    (268 days)

    Product Code
    KZM
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROMUSCULAR TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. To treat temporomandibular joint (TMJ) disfunction and associated pain 2. To relieve symptoms associated with muscle spasm 3. To relax muscles and establish a physiologic occlusion 4. To take occlusal registrations 5. To take denture impressions 6. To increase local blood circulation 7. To maintain or increase mandibular range of motic
    Device Description
    The DOLOTENS DENTAL TM2 is an ultra low frequency muscle stimulator, sending an electrical impulse to the muscles via the nerves in order to provide a minor level of muscle contraction. This gentle contraction of the muscles provides a pumping action for the blood increasing circulation in the muscles. Muscle spasm is relieved because fresh nutrients are brought into the muscles and waste products are pumped out.
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