O2Vent W

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…

Registry build 21.09.26

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.

8manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code LRK
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

Regulatory record for O2Vent W
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) K171316
Record published 2019-04-30
Record revised 2025-02-10 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for O2Vent W
Catalogue number Size Status
O2Vent W In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer