FDA Product Code LRK: Device, Anti-snoring

Oral appliance therapy provides an effective non-CPAP option for snoring and mild obstructive sleep apnea. FDA product code LRK covers anti-snoring devices worn in the mouth during sleep.

These mandibular advancement or tongue retention devices reposition the jaw or tongue to maintain airway patency during sleep, reducing snoring and apnea events. They are custom-fabricated or thermoplastic appliances worn during sleep.

LRK devices are Class II medical devices, regulated under 21 CFR 872.5570 and reviewed by the FDA Dental panel.

Leading manufacturers include Somnomed, Inc., Sleeping Well, LLC and Oventus Manufacturing Pty, Ltd..