Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in AustraliaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list SomnoMed and its 1 subsidiaries with 13 510(k) clearances. The most recent is a 510(k) clearance dated Jun 12, 2026: Virtus.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, SomnoMed and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 12, 2026 | VirtusK261366 · LRK | 510(k) clearances |
| Oct 3, 2024 | Rest Assure SystemK233497 · PLC | 510(k) clearances |
| Sep 4, 2024 | DreamClearK240646 · GWL | 510(k) clearances |
| May 8, 2019 | SomnoDent AvantK183443 · LRK | 510(k) clearances |
| Sep 20, 2016 | SomnoDent ALPHAK162306 · LRK | 510(k) clearances |
| Jun 18, 2015 | 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-recorderK150369 · PLC | 510(k) clearances |
| Jun 20, 2014 | SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEXK140278 · LRK | 510(k) clearances |
| May 17, 2013 | SOMNODENT HERBST; CLASSIC, FLEXK130558 · LRK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
