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O2Vent T

FDA UDI

Class II (US FDA UDI)

by Oventus Manufacturing Pty, Ltd.

Identity

Trade Name
O2Vent T FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
The O2Vent T is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent T is made up of three 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 2. The Lower Tray fitted over the lower teeth, positions the jaw for mandibular advancement. The Upper and Lower Trays have a "landing area” customized to the patientsteeth and made from medical grade polymers. 3. The Upper and Lower Trays are connected together with a connector. A hook mechanism attached to the Upper Tray fits into a socket attached to the Lower Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. An Adjustment Key for the O2Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position. FDA UDI
Model / Reference
O2Vent T FDA UDI
Description
The O2Vent T is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent T is made up of three 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 2. The Lower Tray fitted over the lower teeth, positions the jaw for mandibular advancement. The Upper and Lower Trays have a "landing area” customized to the patientsteeth and made from medical grade polymers. 3. The Upper and Lower Trays are connected together with a connector. A hook mechanism attached to the Upper Tray fits into a socket attached to the Lower Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. An Adjustment Key for the O2Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position. FDA UDI

Identifiers

Primary DI / UDI-DI
09351567000011 FDA UDI
510(k) Number
K161832 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

O2Vent T by Oventus Manufacturing Pty, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oventus Manufacturing Pty, Ltd.

Sources (1)

  • FDA UDI e90e573e-ccb7-443e-8d05-3800c792d054 35 fields · synced Jun 8, 2026