Manufacturer registered with FDA
Somnomed, Inc.
Plano, TX, United States. Lists 6 dental device types with FDA across 3 registered establishments, and holds 11 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 23
- 510(k) clearances
- 112005–2026
- Markets registered in
- 25 registrations outside the US
- Establishments
- 3Australia, Philippines, United States
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Somnomed, 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 | Somnomed, Inc. | 11 clearances | 2005–2026 | Below |
| Australia | TGA | Registration holder | Somnomed Ltd | 5 | 2006–2026 | 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 Somnomed, 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 | ClassicClassic Lingual-LessFlexFusion ClassicFusion FlexHerbst Advance ClassicHerbst Advance FlexHerbst Shim ClassicHerbst Shim FlexHerbst Telescopic Classic 6 moreHerbst Telescopic FlexSomnoDent AirSomnoDent Air+SomnoDent AVANTSomnoDent Herbst Advance EliteVirtus | 2007 |
| Sleep Appliances with Patient MonitoringPLC · Class 2 | — | Maker | DentiTracSomnoDent AVANT | 2015 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | FlexSomnoDent Air+ | 2011 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | SomGauge | 2015 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Morning Repositioner | 2015 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | SomTabs | 2014 |
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 Somnomed, Inc. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Jun 2026 | K261366 | Virtus | LRK Anti-Snoring Device |
| 3 Oct 2024 | K233497 | Rest Assure System | PLC Sleep Appliances with Patient Monitoring |
| 8 May 2019 | K183443 | SomnoDent Avant | LRK Anti-Snoring Device |
| 20 Sep 2016 | K162306 | SomnoDent ALPHA | LRK Anti-Snoring Device |
| 18 Jun 2015 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder | PLC Sleep Appliances with Patient Monitoring |
| 20 Jun 2014 | K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | LRK Anti-Snoring Device |
| 17 May 2013 | K130558 | SOMNODENT HERBST; CLASSIC, FLEX | LRK Anti-Snoring Device |
| 30 May 2012 | K121340 | SOMNODENT G2 | LRK Anti-Snoring Device |
| 28 Mar 2011 | K102521 | PANTINO PRO POSITINER | LRK Anti-Snoring Device |
| 30 Jan 2008 | K073004 | SOMNOMED BFLEX | LRK Anti-Snoring Device |
| 12 Jul 2005 | K050592 | SOMNOMED MAS RXA | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOMNOMED INC.FDA reg. 3005598536 | Plano, TX, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
| SomnoMed Phillipines Inc.FDA reg. 3009440973 | Makati City National Capital Region, Philippines | Manufacturer |
| SOMNOMED, LTD.FDA reg. 3005343849 | CROWS NEST New South Wales, Australia | Specification developer |
Other names on FDA records
SomnoMed Phillipines Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9071127). 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.