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A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and TMJ syndrome through reduction of trigeminally innervated muscular activity

TMJ Relax™ is durable medical equipment in the form of a mouthguard that is fitted to the teeth that temporarily provides traction on the mandible such that it repositions the mandible to reduce muscle tension. The device is a removeable home use product that a consumer may wear up to 22 hours per day, in other words except when eating or during sports activities. The TMJ Relax™ system is a single or series of appliances prescribed for patients with a history of a diagnosis of temporomandibular joint disorder and/or migraines/tension headaches. The device is a one-part removeable oral appliance fitted on the mandibular or maxillary teeth that repositions the mandible while sleeping or during sedentary daytime use. The appliance is patient fitted by using a computer aided manufacturing protocol.

- 1. A device to be used for the treatment of sleep bruxism and - 2. As an aid in the treatment of associated tension/migraine type headaches in adults.

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