O2Vent W

Primary DI
09351567000028
Brand
O2Vent W
Company
OVENTUS MANUFACTURING PTY LTD
Model
O2Vent W
Device description
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.
Published
2019-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171316000O2Vent WOventus Manufacturing Pty, Ltd.2017-07-11LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351567000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351567000028093515670000289351567000028

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-835-0116support@oventusmedical.com

Regulatory Flags#

DUNS number
748034696
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351567000363O2Vent OptimaO2Vent Optima MiniO2VBM2021-12-02
09351567000035O2Vent OptimaO2Vent Optima2020-01-03
09351567000004O2Vent Mono (OVENT)O2Vent Mono2019-05-30
09351567000011O2Vent TO2Vent T2019-04-30

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