Intraoral Pressure Gradient Device
The Intraoral Pressure Gradient Device is an electrically powered dental device that reduces pressure in the oral cavity via a noninvasive oral interface to create a continuous positive pressure gradient from the airway to the oral cavity, urging the soft palate and tongue forward during sleep to treat obstructive sleep apnea. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance, and is eligible for third-party review. The product code is OZR, with regulation number 872.5570 under the Dental specialty, reviewed by the anesthesiology panel.
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Basic Information
- Product Code
- OZR
- Device Class
- FDA class 2
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220907 | The iNAP One Sleep Therapy System | Jun 16, 2023 | Substantially Equivalent | Somnics, Inc. |
| K193460 | The iNAP One Sleep Therapy System | May 26, 2020 | Substantially Equivalent | Somnice, Inc. |
| K132003 | WINX SLEEP THERAPY SYSTEM | Jun 13, 2014 | Substantially Equivalent | Apnicure, Inc. |
| K130538 | WINX SLEEP THERAPY SYSTEM | May 22, 2013 | Substantially Equivalent | Apnicure, Inc. |
| K122130 | WINX SLEEP THERAPY SYSTEM | Oct 31, 2012 | Substantially Equivalent | Apnicure, Inc. |
| K111549 | ATTUNE SLEEP APNEA SYSTEM | Mar 30, 2012 | Substantially Equivalent | Apnicure, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.