OZR — Intraoral Pressure Gradient Device Class II
FDA product code OZR covers "Intraoral Pressure Gradient Device", a Class II medical device regulated under 21 CFR 872.5570. Submissions are reviewed by the Dental panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OZR
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- 510(k)
- Review Panel
- AN
- Medical Specialty
- Dental
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220907 | Somnics | The iNAP One Sleep Therapy System | Jun 16, 2023 |
| K193460 | Somnice | The iNAP One Sleep Therapy System | May 26, 2020 |
| K132003 | Apnicure | WINX SLEEP THERAPY SYSTEM | Jun 13, 2014 |
| K130538 | Apnicure | WINX SLEEP THERAPY SYSTEM | May 22, 2013 |
| K122130 | Apnicure | WINX SLEEP THERAPY SYSTEM | Oct 31, 2012 |
| K111549 | Apnicure | ATTUNE SLEEP APNEA SYSTEM | Mar 30, 2012 |