Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012539501

FEI Number

3012539501

Entity Name

Open Airway Dental Solutions Australia Pty Ltd

City/State/Country

Taringa Queensland, AU

Establishment Address

5 Moorak Street, Taringa Queensland 4068, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Open Airway Dental Solutions (Owner Number: 10052099)

Owner / Operator Contact Address

5 Moorak Street, Taringa, AU-QLD 4068, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161832

PMA Number

N/A

All Registered Proprietary Names

Device, anti-snoring Device, anti-snoring Device, anti-snoring - O2Vent Optima; O2Vent Optima Connect; O2Vent Optima Mini; O2Vent Optima Mini Connect EHY / Tray, Impression, PREFORMED - Oventus Bite Fork EHY / Tray, Impression, PREFORMED Device, anti-snoring

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2016-06-13
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2019-09-03
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-03-26
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2016-10-12

Official Correspondent

Masoud Vahidi

US Agent Details

Masoud Vahidi Business: Open Airway Dental Solutions LTD Email: masoud@openairway.com Phone: (858) 6101444

Related Public Records

Same Entity

Open Airway Dental Solutions

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012539501. Last updated year: 2026. Please use registration number 3012539501 when referencing this establishment in official correspondence.