FDA Product Code OZR: Intraoral Pressure Gradient Device
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.
Leading manufacturers include Somnice, Inc. and Somnics, Inc..
6
Total
6
Cleared
240d
Avg days
2012
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Intraoral Pressure Gradient Device Devices (Product Code OZR)
6 devices
Cleared
Jun 16, 2023
The iNAP One Sleep Therapy System
Somnics, Inc.
Anesthesiology
444d
Cleared
May 26, 2020
The iNAP One Sleep Therapy System
Somnice, Inc.
Anesthesiology
162d
About Product Code OZR - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code OZR since 2012, with 6 receiving FDA clearance (average review time: 240 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.