Data / Medical devices / Australia / Somnomed, Ltd.
Somnomed, Ltd.: FDA-registered device maker in CROWS NEST New South Wales, Australia, 9 510(k) clearances
Somnomed, Ltd. is registered with the FDA (registration 3005343849) in CROWS NEST New South Wales, Australia. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005343849
- Address
- Level 3, 20 Clarke ST., CROWS NEST New South Wales, Australia, NSW 2065
- Owner or operator
- SOMNOMED INC. (9071127)
- Roles
- Specification developer
- First device listed
- January 10, 2007
- Registered through
- 2027
- Brand names listed
- Classic, Classic Lingual-Less, DentiTrac, Flex, Fusion Classic, Fusion Flex, Herbst Advance Classic, Herbst Advance Flex and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Specification developer | accessdata.fda.gov |
| Sleep Appliances With Patient Monitoring | PLC | 2 | Specification developer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 12, 2026 | K261366 | Virtus | LRK | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| October 3, 2024 | K233497 | Rest Assure System | PLC | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| May 8, 2019 | K183443 | SomnoDent Avant | LRK | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| June 18, 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 | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| June 20, 2014 | K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | LRK | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| May 17, 2013 | K130558 | SOMNODENT HERBST; CLASSIC, FLEX | LRK | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| December 13, 2011 | K102909 | SOMNOBRUX SPLINTS | MQC | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| January 30, 2008 | K073004 | SOMNOMED BFLEX | LRK | Substantially Equivalent | Somnomed, Inc. | accessdata.fda.gov |
| July 12, 2005 | K050592 | SOMNOMED MAS RXA | LRK | Substantially Equivalent | Somnomed, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Sleep Appliances With Patient Monitoring
- All makers of Device, Anti-Snoring
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Tray, Impression, Preformed
Updated June 12, 2026. 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.