O2Vent W
OVENTUS MANUFACTURING PTY LTD · Model O2Vent W · UDI-DI 09351567000028
Description
The O2Vent W is an oral appliance and is intended to reduce or alleviate 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 breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-27 | Prismatik Dentalcraft, Inc. | Due to device not having FDA Clearance |
| 2025-10-09 | Myofunctional Research Company USA | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. |
| 2022-05-23 | Dental Choice Holding Llc | The device was marketed and sold in the US without FDA clearance. |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently place |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed |
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