Somnomed Inc.
CROWS NEST New South Wales, AU
SOMNOMED INC. appears in FDA device records in CROWS NEST New South Wales, AU. FDA records list 12 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Somnomed Inc. between 2005 and 2026. The busiest year on record is 2011, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261366 | Virtus | LRK | Substantially Equivalent | |
| K233497 | Rest Assure System | PLC | Substantially Equivalent | |
| K183443 | SomnoDent Avant | LRK | Substantially Equivalent | |
| K162306 | SomnoDent ALPHA | LRK | Substantially Equivalent | |
| 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 | |
| K140278 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX | LRK | Substantially Equivalent | |
| K130558 | SOMNODENT HERBST; CLASSIC, FLEX | LRK | Substantially Equivalent | |
| K121340 | SOMNODENT G2 | LRK | Substantially Equivalent | |
| K102909 | SOMNOBRUX SPLINTS | MQC | Substantially Equivalent | |
| K102521 | PANTINO PRO POSITINER | LRK | Substantially Equivalent | |
| K073004 | SOMNOMED BFLEX | LRK | Substantially Equivalent | |
| K050592 | SOMNOMED MAS RXA | LRK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005598536 | 3005598536 | SOMNOMED INC. | 6513 Windcrest Dr Ste 100, Plano, TX 75024 US | 2026 | |
| 3005343849 | 3005343849 | SOMNOMED, LTD. | LEVEL 3, 20 CLARKE ST., CROWS NEST New South Wales NSW 2065 AU | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Somnomed Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain