Identity
- Trade Name
- O2Vent Mono (OVENT) FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- O2Vent Mono FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09351567000004 FDA UDI
- 510(k) Number
- K160234 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
MR Unsafe FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
O2Vent Mono (OVENT) by Oventus Manufacturing Pty, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Oventus Manufacturing Pty, Ltd.
Sources (1)
- FDA UDI 1393c5db-a0e2-40d8-b08b-6ba705de6b17 34 fields · synced May 30, 2026