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Intraoral Pressure Gradient Device

FDA product code OZR · 5 cleared devices

Class 2 Dental
Regulation
21 CFR 872.5570
Review panel
AN
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2012-03-30 – 2023-06-16

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.

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