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The Hushd Pro Z-Link device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Hushd Pro Z-Link device series are removable intraoral patient-specific device intended for the treatment of snoring and mild to moderate obstructive sleep apnea. The device consists of custom-made maxillary and mandibular splints that fit over the upper and lower teeth, and are connected via a pair of detachable rigid connectors. When linked, the splints function as a mandibular repositioner by holding the lower jaw in a forward position during sleep, thereby preventing the tongue and soft tissues from collapsing into the airway.

Each device consists of one maxillary and one mandibular splint, designed and manufactured using 3D printing technology. The splints incorporate a pair of integrated studs that are located around the canine area for the maxillary splint and around the first molar area for the mandibular splint. These studs interface with slots on the detachable connectors to securely link the two splints together. This configuration permits the mandible to advance from the baseline position, offering improved patient comfort.

Titration is achieved by replacing the connectors with another pair of a different size. The connectors are available in 1.0 mm incremental lengths, allowing progressive mandibular advancement according to patient tolerance and clinical need. A standard set includes six pairs of connectors, ranging from -1 mm to +5 mm protrusion, while an extended set ranging from +6 mm to +10 mm is available upon request, providing a maximum mandibular protrusion of 10 mm.

The connectors are not elastic and do not contain adjustment mechanisms such as pistons, screws, straps, or repositioning elastics. The rigid connectors are manufactured with medical grade nylon PA12 using commercial injection molding process and are marked for easy identification.

The splints of this device are manufactured using selective laser sintering (SLS) 3D printing with EOS PA2200 polyamide (nylon) PA12 material. This material offers excellent mechanical properties, long-term stability, and has a history of safe use in oral medical devices. The manufacturing process includes mechanical or chemical polishing, cleaning, and rigorous quality control prior to packaging.

The Hushd Pro Z-Link is available for prescription only and designed based on optical or physical impressions taken by a licensed healthcare provider. The splints and connectors are designed exclusively by the device manufacturer and its authorized partners to ensure consistent quality and performance.

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