O2Vent W - The O2Vent W is an oral appliance and is intended - OVENTUS MANUFACTURING PTY LTD

Duns Number:748034696

Device Description: The O2Vent W is an oral appliance and is intended to reduce oralleviate snoring and mild t 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.

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More Product Details

Catalog Number

-

Brand Name

O2Vent W

Version/Model Number

O2Vent W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

Public Device Record Key

c597d572-e62e-4ab2-af6a-670f13c0e997

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OVENTUS MANUFACTURING PTY LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5