Oniris; Oniris Plus

Oniris and Oniris Plus are intraoral mandibular advancement devices designed to reduce snoring and treat mild-to-moderate obstructive sleep apnea in adults. Each device consists of two independent splints (upper and lower trays) custom-fitted at home using a boil-and-bite process, connected by interchangeable advancement hooks that allow mandibular protrusion of up to 6mm (OTC) or 11mm (Rx).

Both subject and predicate devices are mandibular advancement appliances with upper and lower trays made from rigid outer shells with moldable material, customized through boil-and-bite at home. The main difference is in hook attachment: Oniris features an enlarged stopper on the lower tray with an integrated slot for secure attachment via applied pressure and angular rotation, plus a key-like locking system on the upper tray, whereas SmartGuard uses only applied pressure on both trays.

No FDA-recognized consensus standards or guidance documents were specifically cited. Testing was based on internal product specifications and predicate device comparison, using calibrated precision instruments (caliper and scale) with traceability to international standards (Calibration Certificates: FACOM CK311539, RS PRO JS-10).

The subject devices share the same indications for use and mandibular advancement principle as the predicate SmartGuard. Nonclinical bench testing confirmed dimensional conformity, comparable tray geometry, hook function, transparency, and packaging to the predicate. Although Oniris devices are slightly larger and feature improved hook attachment mechanisms (enlarged stopper and key-like locking), these design refinements enhance stability and usability without affecting safety or effectiveness, and comparative testing demonstrated the dimensional differences do not impact intended use or target patient population.