FDA Clears CAD/CAM Milled Oral Appliance by MicroDental Laboratories
The FDA has cleared MicroDental Laboratories’ MicrO2 Obstructive Sleep Apnea Device. A CAD/CAM milled obstructive sleep apnea (OSA) device, the MicrO2 offers dentists a new option for treating the growing number of patients diagnosed with OSA.
“Dentists are the front line for screening and managing patients with obstructive sleep apnea,” says Kim Bradshaw, CEO and president of MicroDental Laboratories, in a release. “Many of our partner dentists asked for a small, precise, and easy to use obstructive sleep apnea device. The MicrO2 device has been designed, from the very beginning, with these goals in mind.”
Bill Dickerson, DDS, FAACD, LVIM, says, “I can honestly say that I don’t think there is a better appliance out there. With its lingualess design, airway constriction preventing fins, and unobtrusive size, this device is a winner.”
Featuring a patent pending design and a precision milling production process, the MicrO2 uses a PMMA material that is cured under controlled conditions. These aspects allow the MicrO2 to be small yet strong, precise, and predictable. The MicrO2 also features a unique approach to titration that is intended to make the device easier to use for the dentist and the patient.
“The MicrO2 does not require patients to manage any mechanical adjustments, such as turning screws, or changing positions with elastics. Instead the MicrO2 comes with one pair of Upper and Lower arches set to the prescription, and a second pair set in any amount of advancement increments. Advancements are easily achieved by simply removing the current Upper or Lower arch device and inserting the next advancement device in the MicrO2 series,” says Laura Sheppard, sr director of compliance and regulatory affairs for MicroDental.
“MicroDental Laboratories has a legacy of partnering with dentists who are committed to enhancing the lives of their patients,” says Len Liptak, VP of sales and marketing for MicroDental. “With our FDA registered MicrO2 device, we look forward to partnering with these dentists as they manage the growing number of patients who are diagnosed with this serious condition.”