VitalSleep is made of medical-grade outer plastic and inner thermal plastic that softens to mold to your teeth. The 3 materials are polypropylene (PP), and ethylene-vinyl acetate (EVA), and the screws are nylon. All of the materials have undergone testing that includes toxicology, sensitivity, and biocompatibility assessments.
It does not contain BPA, latex, silicone, or metal. The materials are made in the USA and are formulated for medical applications that require FDA compliance. FDA-cleared means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval.