Luco Hybrid OSA Appliance is available for licensing by registered dental laboratories in Canada, the United States and the European Union. It is government registered in all of these regions with medical representation.
Canada MDEL 5315
USA K130797. K160477
MHRA (European Union)
Dental laboratories are the lifeline of dental offices, providing quality service as well as being a wealth of information on new techniques and new products.
Sleep apnea is an enormously under-serviced area of dentistry, with only a scattering of dentists actually providing this service on a regular basis. Until recently, I was one of two dentists in our entire corner of the province providing this service. 22 million people in the US suffer from sleep apnea and only a fraction are being treated. The AASM state up to 25 million people are at risk of OSA in the USA! These numbers cannot and should not be ignored when dentistry is in the unique position to offer effective treatments.
Sleep-related bruxism, as a dental field of treatment, is completely untapped. Dental schools are currently not teaching about this common disorder and dentists continue to fabricate upper or lower night guards that are of little to no use in treating this disorder. This disorder affects 10-12% of the population (the numbers vary wildly up to 33% but the consensus is that 10-12% are affected). This translates into 32 million people conservatively. With the latest research linking sleep-related bruxism to cardiovascular disease, this is one of the most important fields of dentistry, yet it is being ignored.
The Luco Hybrid device brings to dentistry and dental laboratories an excellent opportunity to tap into this field of care affecting this large part of the adult population.
We are currently licensing dental laboratories to manufacture the Luco Hybrid device. Dr. Luco is available to lecture about these disorders in your region to help train new dentists in this field. He has presented internationally on this subject.
If you are a dental lab looking to move into sleep apnea/sleep-related bruxism appliances or already have a lineup and are looking to expand, please complete the form at the bottom of this page and one of our representatives will contact you with more information.
Some of the advantages of licensing include:
- Establishing yourself as a leader in your area by offering treatment of sleep-related bruxism/sleep apnea/snoring with the Luco Hybrid Device
- Gaining more clients as dentists begin using this device
- Benefit from Dr. Luco’s expertise in these fields
- Expanding your lab services to include this device
- Providing webinars by Dr. Luco on these conditions to clients in your region
It is important to note the Luco Hybrid is not just another OSA appliance. It has two FDA clearances: one for medical treatment and one for dental treatment of sleep-related bruxism, making it a true hybrid and in a class of its own.
The first, K130797, is medical and requires the oversight of a medical doctor, usually following an overnight sleep study.
The second, K160477, is dental and any dentist with training in this field is allowed to make this device without medical oversight.
The Luco Hybrid device is classified as a type 2 medical / dental device by the FDA.
The Luco Hybrid is only the second FDA cleared dental treatment of migraine headaches after the NTI appliance K010876, in 2001.
It is the only dental appliance clinically proven to reduce the Trigeminal Cardiac Reflex increase in heart rate and blood pressure (and risk of hypertension and heart disease) associated with sleep-related bruxism.
The Luco Hybrid is also registered in the Canada, the USA, European Union, and the United Kingdom and is available for licensing in these regions as well.
For more information on licensing this advanced treatment, please complete the following form and a representative will contact you with more information.