Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue

The Advanced Anti Snoring Device 4.0 Clear/Blue is an intraoral mandibular advancement device intended to help reduce snoring in people 18 years of age or older. It works by gently repositioning the lower jaw forward to open the airway and allow smoother airflow during sleep, thereby reducing throat tissue collapse and vibrations that cause snoring.

The subject device is a custom-fitted, reusable, non-sterile intraoral device made of polycarbonate resin and ethylene vinyl acetate copolymer. Key differences from the predicate include: maximum mandibular advancement of 6mm (versus 4mm), advancing in 1mm increments, and removal of a small anterior protrusion to improve wearing comfort. Both devices use injection molding and reposition the mandible anteriorly.

ISO 10993-1 for biocompatibility assessment. Physical property tests included flexural strength and modulus, tensile strength and elongation at break, water absorption, melting temperature, and density.

The subject device is substantially equivalent because it shares the same product code (LRK), classification (Class II), intended use, materials, and manufacturing process as the predicate. The two design differences—increased jaw advancement range (6mm vs 4mm) and removal of the anterior protrusion—do not impact safety or effectiveness; the greater advancement provides enhanced airway expansion while the protrusion removal merely improves comfort. Non-clinical testing confirms the device meets design specifications and biocompatibility standards equivalent to the predicate.