Product code OZR

Device name

Intraoral Pressure Gradient Device

Medical specialty

Dental

Device class

2

Regulation number

872.5570

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset