.FDA-Cleared Snoring Solution FDA-cleared (K200657) Class II medical device proven to reduce snoring in adults 18+ by advancing the lower jaw (mandible) to improve airflow, compliant with 21 CFR 872.5570.
Customizable & Comfortable Fit Features boil-and-bite thermoplastic trays (upper/lower) with polycarbonate shells and EVA lining for a personalized fit. Includes 6 adjustable advancement bars (1mm increments, up to 6mm protrusion) for optimal comfort.
Clinically Validated Design Substantially equivalent to predicate devices (SnoreRx K170285, Snoreeze K181396) with identical ISO 10993-1 biocompatible materials (non-toxic, non-irritating) and mandibular advancement technology.
Easy Home Use & Maintenance Reusable and easy to clean—rinse daily with toothpaste or effervescent tablets. Passed human factors testing (ISO 14971) for intuitive at-home customization.
Safe & Drug-Free No clinical downtime or prescriptions needed. Rigorously tested for tensile/flexural strength (ISO 527/178) and water absorption (ISO 62). Ideal for long-term use with prolonged mucosal contact safety.
