O2Vent Mono (OVENT)

Primary DI
09351567000004
Brand
O2Vent Mono (OVENT)
Company
OVENTUS MANUFACTURING PTY LTD
Model
O2Vent Mono
Device description
The OVENT device is for the treatment of snoringand/or obstructive sleep apnea and is comprised of:• A titanium bimaxillary oral appliance whichcomprises, in one device, a lower tray fitted over thelower teeth and an upper tray fitted over the upperteeth.• A dental polymer material in each tray which is incontact with and retaining in position, the user’s topand bottom teeth.• The lower jaw is retained in an advanced position tohelp open up the natural airway and alleviate theuser’s snoring condition.• A breathing port at the front of the appliance with anenclosed airway on each side which passes betweenthe teeth and the cheek. Each airway delivers the airat the rear of the mouth typically between the lastteeth. The airways allow the user to breathe with themouth closed.
Published
2019-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
K160234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160234000OVENTOventus Manufacturing Pty, Ltd.2016-03-17LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351567000004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351567000004093515670000049351567000004

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

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
09351567000028O2Vent WO2Vent W2019-04-30
09351567000363O2Vent OptimaO2Vent Optima MiniO2VBM2021-12-02
09351567000035O2Vent OptimaO2Vent Optima2020-01-03
09351567000011O2Vent TO2Vent T2019-04-30

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