Intraoral Pressure Gradient Device

OZR · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5570

Classification

FDA Product Code: OZR
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 872.5570
Review panel: AN
Medical specialty: Dental
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown