Device Classification Name: Device, Anti-Snoring 510(k) Number: K250482 Device Name: Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue Brand name: Difiney Manufacture: Fissiontech LLC Technological Features: Advanced Anti Snoring Device 4.0 helps reduce snoring by moving the lower jaw forward to open your airway to improve breathing allowing air to flow freely without the unhealthy and annoying sound of snoring. Materials: - Polycarbonate resin - Ethylene vinyl acetate copolymer Desirable Characteristics: Home use, heat sensitive / moldable, adjustable jaw advancement position Specifications: - Custom-fitted intraoral device - Physical: - Mechanical: - Repositions mandible anteriorly - Single use: - Reusable Mandibular advancement range: Repositions mandible anteriorly up to 6 mm at 1mm increment Manufacturing Process: Injection molding Sterility: Non-sterile Biocompatibility: ISO 10993 Indications for use The Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.