OZR

Intraoral Pressure Gradient Device

Product code

OZR

Device name

Intraoral Pressure Gradient Device

Device class

Class 2

21 CFR

21 CFR 872.5570

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification definition

This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward. It is intended to be used while a patient is sleeping to treat obstructive sleep apnea.

Definition text from the FDA device classification database (U.S. federal government work, public domain).