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The Food and Drug Administration (FDA) recently sent a written warning to Splintek, a division of Power Products, to stop marketing its Sleep Right Adjustable Night Guard in the US for over-the-counter use by 12- to 18-year-old children. The device is meant to protect patients from teeth clenching and grinding.
According to the letter, Splintek obtained marketing clearance for the Sleep Right Adjustable Night Guard for prescription use only, and for patients ages 18 and older. It did not get marketing approval or clearance to offer the mouth guard as an OTC product for use by children ages 12 to 18 years old, which is a violation of law, and may result in regulatory action being initiated by the FDA.