O2Vent W
- Primary DI
- 09351567000028
- Brand
- O2Vent W
- Company
- OVENTUS MANUFACTURING PTY LTD
- Model
- O2Vent W
- Device description
- The O2Vent W is an oral appliance and is intended to reduce oralleviate snoring and mild to moderate obstructive sleep apnea(OSA).The O2Vent W is made up of two parts:1. The Upper Tray fitted over the upper teeth, with the breathingport at the front leading to the airways on each side to the rear ofthe appliance, is made from medical grade titanium (3D printed).The upper titanium tray has two side protrusions (wings) thatextend vertically down to interface with the lower acrylic trayfor titration of the device. The upper tray is lined with acrylicinsert, and is customized to patient bite and impression.2. The Lower Tray customized to the lower teeth, positions thelower jaw forward, preventing the soft tissue of the throat fromcollapsing and obstructing the airway. The lower tray features anadjuster assembly set into the acrylic, comprising of an adjusterblock and also adjustment screws each located on either side ofthe lower arch.The adjuster block interfaces with the side protrusions on theupper tray to provide titration. The screws are adjusted with anAdjustment Key for mandibular adjustment to be set by thedentist and/or by the patient under the direction of the dentist.
- Published
- 2019-04-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| LRK | Device, Anti-Snoring |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K171316 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09351567000028 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09351567000028 | 09351567000028 | 9351567000028 |
GMDN Terms#
| Term | Definition |
|---|---|
| Mandible-repositioning sleep-disordered breathing orthosis | A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 1-866-835-0116 | support@oventusmedical.com |
Regulatory Flags#
- DUNS number
- 748034696
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 09351567000363 | O2Vent Optima | O2Vent Optima Mini | O2VBM | 2021-12-02 |
| 09351567000035 | O2Vent Optima | O2Vent Optima | 2020-01-03 | |
| 09351567000004 | O2Vent Mono (OVENT) | O2Vent Mono | 2019-05-30 | |
| 09351567000011 | O2Vent T | O2Vent T | 2019-04-30 |
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