The US Food and Drug Administration (FDA) has granted 510(k) clearance for SomnoMed’s SomnoDent G2 technology.
The SomnoDent G2 technology features a click-to-fit design, which provides controlled measurement of a patient’s mandible position, to treat obstructive sleep apnea (OSA).
Ralf Barschow, SomnoMed CEO, said that with the new SomnoDent G2 and Somnomed MATRx both now FDA-cleared, the company is able to offer oral appliance treatment and diagnostic solutions for OSA patients.
"These revolutionary, premium product innovations continue our focus on evidence-based, quality clinical outcomes for patients," Barschow added.
The SomnoDent G2 integrates modular adjustment parts, which are distinctively identified and provide instant advancement of the G2 splints.
The extended range of motion of the device will provide more treatment options, according to the company.
SomnoMed’s proprietary materials, which are metal free and 20% smaller than SomnoMed’s current range of sleep apnea devices, are included in the SomnoDent G2.
SomnoDent G2 is available through qualified SomnoMed Preferred Dental Network partners.
The device is protected by a newly designed premium packaging and travel case when not in use and is accompanied by an adjustment kit, which stores and organises the modular adjustment parts.
SomnoMed is a public company providing diagnostic and treatment solutions for sleep-related breathing disorders, including obstructive sleep apnea, snoring and bruxism.