Data / Medical devices / Australia / Open Airway Dental Solutions Australia Pty Ltd
Open Airway Dental Solutions Australia Pty Ltd: FDA-registered device maker in Taringa Queensland, Australia, 4 510(k) clearances
Open Airway Dental Solutions Australia Pty Ltd is registered with the FDA (registration 3012539501) in Taringa Queensland, Australia. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 29, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012539501
- Address
- 5 Moorak Street, Taringa Queensland, Australia, 4068
- Owner or operator
- Open Airway Dental Solutions (10052099)
- Roles
- Manufacturer
- First device listed
- June 13, 2016
- Registered through
- 2026
- Brand names listed
- Device, anti-snoring, Device, anti-snoring - O2Vent Optima; O2Vent Optima Connect; O2Vent Optima Mini; O2Vent Optima Mini Connect, EHY / Tray, Impression, PREFORMED, EHY / Tray, Impression, PREFORMED - Oventus Bite Fork
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 29, 2019 | K190236 | O2Vent Optima | LRK | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. | accessdata.fda.gov |
| July 11, 2017 | K171316 | O2Vent W | LRK | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. | accessdata.fda.gov |
| September 23, 2016 | K161832 | O2VENT T | LRK | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. | accessdata.fda.gov |
| March 17, 2016 | K160234 | OVENT | LRK | Substantially Equivalent | Oventus Manufacturing Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.