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OZRClass II

Intraoral Pressure Gradient Device

21 CFR 872.5570 / Dental
FDA source (opens on fda.gov)

OZR is the FDA product code for Intraoral Pressure Gradient Device, a class II device type, regulated under 21 CFR 872.5570. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OZR
Device name
Intraoral Pressure Gradient Device
FDA 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.
Regulation
21 CFR 872.5570
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code OZR

By decision year
6 clearances under product code OZR with a decision year between 2012 and 2023, 2012 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OZR by decision year
YearClearances
20122
20131
20141
20201
20231

Applicants with the most clearances

Product code OZR
Applicants holding the most 510(k) clearances under product code OZR
ApplicantClearances
Apnicure, Inc.4
Somnice, Inc.1
Somnics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code