Manufacturer registered with FDA
Open Airway Dental Solutions
Taringa, Australia. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 25 registrations outside the US
- Establishments
- 1Australia
Registered in 2 markets
Where regulators' registries name Open Airway Dental Solutions as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Open Airway Dental Solutions | 2 device types | — | Below |
| Australia | TGA | Manufacturer | Open Airway Dental Solutions Australia Pty Ltd | 5 | 2023–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Open Airway Dental Solutions currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Device, anti-snoringDevice, anti-snoring - O2Vent Optima; O2Vent Optima Connect; O2Vent Optima Mini; O2Vent Optima Mini Connect | 2016 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | EHY / Tray, Impression, PREFORMEDEHY / Tray, Impression, PREFORMED - Oventus Bite Fork | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Open Airway Dental Solutions lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Oventus Manufacturing Pty, Ltd. (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Aug 2019 | K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | LRK Anti-Snoring Device |
| 11 Jul 2017 | K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | LRK Anti-Snoring Device |
| 23 Sep 2016 | K161832 | O2VENT T | Oventus Manufacturing Pty, Ltd. | LRK Anti-Snoring Device |
| 17 Mar 2016 | K160234 | OVENT | Oventus Manufacturing Pty, Ltd. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Open Airway Dental Solutions Australia Pty LtdFDA reg. 3012539501 | Taringa Queensland, Australia | Manufacturer |
Other names on FDA records
Open Airway Dental Solutions Australia Pty Ltd
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052099). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.