SleepTight Mouthpiece is an FDA cleared mouthpiece which is designed to reduce snoring. In addition, it has been cleared by the FDA for the treatment of mild to moderate sleep apnea. Included are a mouthpiece (2), a fitting handle and a fitting case. The SleepTight Mouthpiece does not contain latex of BPA. You can fit the mouthpiece in 5 minutes at home with boiling water. GTIN: 864982000423