Manufacturer registered with FDA
Airway Management, Inc.
Farmers Branch, TX, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 10
- 510(k) clearances
- 52006–2018
- Markets registered in
- 47 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Airway Management, Inc. 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 | Airway Management, Inc. | 5 clearances | 2006–2018 | Below |
| Canada | Health Canada | Registration holder | AIRWAY MANAGEMENT | 4 | 2013–2017 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | AIRWAY MANAGEMENT INC | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Airway Management Inc. | 1 | — | 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 Airway Management, Inc. 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 | dreamTAPMyTAPNylon flexTAPTAP 3 EliteTAP ITAP IIITAP T | 2003 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | THERMOBLEND | 2004 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | BITE REGISTRATION; TAP GAUGE | 2011 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | AM Aligner | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Airway Management, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Aug 2018 | K181482 | myTAP2 | LRK Anti-Snoring Device |
| 10 Aug 2016 | K160239 | TAP 3, TAP 1 | PLC Sleep Appliances with Patient Monitoring |
| 12 Dec 2006 | K062951 | TAP III ANTI-SNORING DEVICE | LRK Anti-Snoring Device |
| 12 Jul 2006 | K061732 | TAP-T | LRK Anti-Snoring Device |
| 17 May 2006 | K060388 | TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Gergens Orthodontic Lab (1).
Also lists devices cleared under other names
Airway Management, Inc. 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: Airway Technologies D/B/A Airway Management (1), W. Keith Thornton, D.D.S. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Sep 2025 | K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | LRK Anti-Snoring Device |
| 21 Aug 1997 | K972061 | TOA | W. Keith Thornton, D.D.S. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AIRWAY MANAGEMENT INC.FDA reg. 3003496134 | Farmers Branch, TX, United States | Complaint file establishment, Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059181). 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.