(122 days)
The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.
The Sleep Splint is a prescription only, intraoral appliance that is fitted to the upper and lower teeth, and worn during sleep for the purpose of reducing the incidence of snoring and obstructive sleep apnea. The Sleep Splint is made of copolyester (acrylic resin for the previous version) and features an orthodontic resin bond which can be custom-fitted by a dentist. It comfortably holds the mandible 5 mm to 7 mm forward.
The providing text does not include information about acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification for the Sleep Splint device, which primarily focuses on establishing substantial equivalence to predicate devices, device description, and intended use. It does not contain clinical study data, performance metrics, or details about how acceptance criteria were established or met through testing.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”