O2Vent T
The O2Vent T is a removable oral appliance worn during sleep to reduce snoring and mild to moderate obstructive sleep apnoea in adults aged 18 or older. It can be used at home or in a sleep…
The O2Vent T is a removable oral appliance worn during sleep to reduce snoring and mild to moderate obstructive sleep apnoea in adults aged 18 or older. It can be used at home or in a sleep laboratory.
Customised upper and lower trays connect through a hook-and-socket mechanism that positions the lower jaw forward. The titanium upper tray includes a front breathing port with channels leading toward the rear, while polymer contact areas fit the patient’s teeth.
Listed Item
The O2Vent T is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent T is made up of three 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 2. The Lower Tray fitted over the lower teeth, positions the jaw for mandibular advancement. The Upper and Lower Trays have a “landing area” customized to the patientsteeth and made from medical grade polymers. 3. The Upper and Lower Trays are connected together with a connector. A hook mechanism attached to the Upper Tray fits into a socket attached to the Lower Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. An Adjustment Key for the O2Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position.
Jaw Adjustment
An adjustment key lets the patient and clinician change mandibular protrusion to the selected position. The appliance’s connection maintains the forward jaw relationship while it is worn.
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Dongguan Yiyao Science & Technology Development Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongyang City Yonoel Outdoor Products Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 32 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai DS Dental Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 8 |
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Oventus Manufacturing Pty, Ltd., Australia |
|---|---|
| FDA product code | LRK |
| Device type | Device, Anti-Snoring |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| 510(k) | K161832 |
| Record published | 2019-04-30 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| O2Vent T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Emerald Herbst | Island Dental LAB DBA Emerald Dental LAB | 141 |
| EMA | The Myerson Company Limited | 94 |
| Apnea Guard | Advanced Brain Monitoring, Inc. | 32 |
| SML | Selane Products, Inc. | 32 |
| SomnoDent Avant | Somnomed, Ltd. | 11 |
| Itus Mouthguardz | Shinrin-Yoku Traders LLC | 8 |
| Virtus | Somnomed, Ltd. | 7 |
| Silent Nite Sleep Appliance with Glidewell Hinge | Prismatik Dentalcraft, Inc. | 7 |
| ZQuiet S.A. | Sleeping Well, LLC | 6 |
| Zyppah | A.M.A. Plastics | 6 |
| AIRvance™ | Medtronic Xomed, Inc. | 5 |
| Anti-snoring, restoration | Modern Dental Laboratory (DG) Co., Ltd. | 4 |
Showing 12 of 209. All products under Device, Anti-Snoring
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190236 | 2019-08-29 |
| K171316 | 2017-07-11 |
| K161832 | 2016-09-23 |
| K160234 | 2016-03-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.