O2Vent Mono (Ovent)
O2Vent Mono, also identified as OVENT, is a removable oral appliance worn during sleep to reduce snoring and mild to moderate obstructive sleep apnea. It is prescribed for adults aged 18…
O2Vent Mono, also identified as OVENT, is a removable oral appliance worn during sleep to reduce snoring and mild to moderate obstructive sleep apnea. It is prescribed for adults aged 18 years and older for use at home or in sleep laboratories.
The titanium appliance holds the upper and lower teeth in polymer-lined trays and retains the lower jaw in an advanced position. A front breathing port connects to enclosed channels along each side of the mouth, delivering air toward the rear of the mouth.
Listed Item
The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of: • A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth. • A dental polymer material in each tray which is in contact with and retaining in position, the user’s top and bottom teeth. • The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user’s snoring condition. • A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.
Fit and Adjustment
The appliance is custom made for each patient in a dental laboratory. Its jaw position is fixed by the fitted insert; changing mandibular advancement requires a new insert. It is supplied nonsterile and can be reused.
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) | K160234 |
| Record published | 2019-05-30 |
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 Mono | 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.