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O2Vent Mono (OVENT)

OVENTUS MANUFACTURING PTY LTD · Model O2Vent Mono · UDI-DI 09351567000004

LRK Prescription

510(k) clearances

2,783

Adverse events (1 deaths)

Recalls

108

Facilities

Description

The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of: • A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth. • A dental polymer material in each tray which is in contact with and retaining in position, the user’s top and bottom teeth. • The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user’s snoring condition. • A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.

Recalls

Date	Firm	Reason
2026-04-27	Prismatik Dentalcraft, Inc.	Due to device not having FDA Clearance
2025-10-09	Myofunctional Research Company USA	Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
2022-05-23	Dental Choice Holding Llc	The device was marketed and sold in the US without FDA clearance.
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2017-09-01	Respire Medical	Potential for device breakage during use
2009-07-27	Medtronic Xomed, Inc.	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently place
2009-07-27	Medtronic Xomed, Inc.	Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.