Bfit Sleep LLC is proud to announce the FDA 510K clearance of its full line of oral sleep appliances. The Bfit Sleep line of appliances was designed by some of the leading sleep, orthodontic and dental professionals in the industry. The appliances offer a low profile, non-rigid design for easy fit and patient comfort. What sets these appliances apart from other industry competitors is its elegant simplicity and dynamic function. Due to the dynamic function, the traditional adjustment of appliances is not required, therefore reducing the number of office visits a patient will have to experience.
Using either the dynamic mild elastic or the spring pull during sleep while muscle atonia may occur, allows the patient the ability to “clench and replace” the jaw into a normal position once atonia subsides. This allows the patient to likely experience a reduction in pain or discomfort that may be experienced when using traditional fixed appliances. The ability for the patient to recover to a more natural position likely reduces sleep arousals and provides a more complete sleep architecture. The design offers dual-layer technology, a soft inner layer that allows for some flexibility and a hard outer acrylic layer for strength. Bfit Sleep Appliances were designed with the professional input of two respected dental and orthodontic professionals, Dr. Emily Bandeen D.D.S. and Dr. Timothy Bandeen D.D.S., M.S. to specifically address the reduction of typical side effects of mandibular advancement with sore temporomandibular joints (TMJ) and unwanted bite and tooth movement experienced by some patients who use rigidly fixed appliances.
Bfit Sleep is changing the landscape of the traditional rigid sleep appliance industry by offering a dynamic approach to mandibular advancement. “We consider the Bfit Sleep line of appliances to be an advanced generation of devices used in the treatment of Mild to Moderate Sleep Apnea,” said Chris Gillette, Inventor and Co-founder of Bfit Sleep, LLC. “Our engineered designs offer mild elastic or spring pull functionality that activates during the stages of sleep when muscle activity is lost. Giving the appliance a sense of auto-titration”.
We are excited to partner with Braebon Medical Corporation, a leader in patient sleep monitoring. Both the Bfit Sleep and Bfit Engage are FDA approved appliances that can be engineered with the DentiTrac Micro-Recorder. “The new auto-titrating Bfit is an exciting evolution in oral appliance design,” said Dr. Richard Bonato, BRAEBON CEO. “BRAEBON welcomes the introduction of DentiTrac into a novel oral appliance which does not require a bite registration,” he added. The Bfit line of appliances offers a comfortable, effective and portable alternative to individuals who have mild to moderate sleep apnea and may not be able to successfully use CPAP. Specifically, the appliances allow professionals in the transportation industry to be treated and show compliance of treatment while working in their field of transport.
Additionally, Bfit Sleep appliances are an effective and compliant combination therapy for CPAP users who need improved mask fit and possible pressure reduction in order to comply with the prescribed CPAP or BiPAP interface. Bfit stands for Better Facial Integrity Treatment, meaning better facial stability so that undesirable mask leaks are a thing of the past.
Bfit Sleep LLC is co-founded by partners Dr. Emily Bandeen D.D.S, Dr. Timothy Bandeen D.D.S, M.S. and Chris Gillette RPSGT. The Bfit line of appliances will launch and welcome orders starting in May 2020. Appliance ordering will be available through dental, orthodontic or medical industry professionals. Appliances can be ordered directly through the Bfit website www.getabfit.com using the convenient online ordering system by providing digital scanning, mailing an alginate impression or models, or by requesting and utilizing the specially designed impression kit by Bfit Sleep LLC. Dentists and
orthodontists will be able to register as a Bfit Sleep Appliance Provider and will be added to our database of Bfit providers worldwide.
Source: Bfit Sleep LLC