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DISCLAIMER Our products and information are not intended to diagnose, prescribe, or replace the need for medical consultation; or prevent or treat medical conditions or disease. Contraindications: Patients with asthma, respiratory disorders, nasal blockage, sleep apnea, loose teeth, advanced periodontal disease, or have other health problems should consult with their physicians. Warnings: The use may cause tooth movement, gingival or dental soreness, soreness in the temporo-mandibular joints, obstruction of oral breathing and increased salivation. 510(k) Safety and Effectiveness statement issued by the Food and Drug Administration (FDA): "The device is substantially equivalent to legally marketed predicate devices", and it is in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act).
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