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- Protecting against teeth grinding, bruxism and jaw clenching. - Short-term pain relief from muscle spasm pain due to occlusal interference. - For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.

The Dr. Hays Bite Guard is designed to assist in the treatment of occlusal disorders resulting in teeth grinding, jaw clenching, and mandibular muscle spasm. The device is comprised of a thin horseshoe shaped plastic (polycarbonate, Lexan) tray filled with a thermoplastic agent (Elvax). The device is supplied to health care practioners to heat, mold, and otherwise custom fit and trim each device to the patient. Materials: the Dr. Hays Bite Guard is made of Lexan and Elvax, the same materials as the Snore Guard device, cleared under K882303. The device is supplied Non-Sterile. The device is packaged in "clean only" condition but is free of manufacturing debris and/or residues. Components are inspected after processing to evaluate and document the removal of manufacturing residue and debris. However, it is recommended that the device be removed from its shipping and packing materials and washed with warm soap and water before use. The device may not be autoclaved.