General Information for Labs

The Luco Hybrid OSA Appliance K130797, K160477

Whether your lab is a general lab interested in moving into the sleep dentistry field or a specialized lab dedicated to sleep dentistry, the Luco Hybrid OSA Appliance is a device you should consider offering.

As of July 29, 2016, this device became the first ever FDA cleared treatment for sleep bruxism and to aid in the treatment of associated tension/migraine type headaches. This was a milestone, as to date there were no approved treatments for sleep bruxism, only a multitude of single arch appliances that protect the teeth from sleep bruxism, breaking after a short period of time.

The effects of sleep bruxism are extensive causing significant injury to the affected individuals including injury to the TMJ, musculature, dentition, periodontium. The development of maxillary and mandibular Tori, antigonial notching, coronoid elongation are all common to sleep bruxism. There is sleep deprivation and a significant decrease in quality of life. It is known result in TMD if left untreated.

The Luco Hybrid OSA Appliance is FDA cleared [K130797] for the treatment of mild to moderate sleep apnea and primary snoring in adults. With the new FDA clearance [K160477], it is the only dual arch appliance with these indications and the only treatment available and FDA cleared for sleep bruxism.

This advanced treatment device may be used by dentists to treat any of these diseases individually or concurrently. Sleep bruxism can be diagnosed and treated by a dentist without medical oversight creating an entirely are a marketing. Sleep bruxism affects 8% of the population (25 million). In 20% of SB cases, it occurs independently (5 million) that dentists now have an FDA market cleared treatment for.

We currently have one lab licensed to manufacture this device in the USA and two in Canada. We are in negotiations with others. If your lab is interested in adding this new treatment to your lineup, please complete the contact form and you will be contacted with more information.

Dr. Ken Luco