OZR · Intraoral Pressure Gradient Device
Dental · 21 CFR 872.5570 · Class 2
Overview
| Product Code | OZR |
|---|---|
| Device Name | Intraoral Pressure Gradient Device |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
Classification Rationale
Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | Jun 16, 2023 | SESE |
| K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | May 26, 2020 | SESE |
| K132003 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | Jun 13, 2014 | SESE |
| K130538 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | May 22, 2013 | SESE |
| K122130 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | Oct 31, 2012 | SESE |
| K111549 | ATTUNE SLEEP APNEA SYSTEM | Apnicure, Inc. | Mar 30, 2012 | SESE |
Top Applicants
- Apnicure, Inc. — 4 clearances
- Somnice, Inc. — 1 clearance
- Somnics, Inc. — 1 clearance
