# Somnomed, Inc.

- Location (FDA's records): Frisco, TX
- FDA decisions: 12 (2005–2026): 12 510(k) clearances
- Names in FDA's records: Somnomed, Inc. (11); Somnomed, Ltd. (1)
- Product codes: LRK (9), PLC (2), MQC (1)
- 510(k) review time since 2016: median 46 days, against 150 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 22 (16 its own); citations of its devices by later devices: 42 (16 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Airway Management, Inc.: 2 (https://510kreport.com/company/airway-management)
- W. Keith Thornton, D.D.S.: 1 (https://510kreport.com/company/w-keith-thornton-dds)
- Mci-Myohealth Systems: 1 (https://510kreport.com/company/mci-myohealth-systems)
- Sentage Corporation D/B/A/ Dental Services Group: 1 (https://510kreport.com/company/sentage-d-b-a-dental-services-group)
- Rj & VK Bird Pty, Ltd.: 1 (https://510kreport.com/company/rj-vk-bird)

## Firms that cite its devices most
- Respire Medical: 2 (https://510kreport.com/company/respire-medical)
- Resmed, Ltd.: 2 (https://510kreport.com/company/resmed)
- Microdental, Inc.: 2 (https://510kreport.com/company/microdental)
- Myohealth Technologies, LLC: 1 (https://510kreport.com/company/myohealth-technologies)
- Gergen'S Orthodontic Lab: 1 (https://510kreport.com/company/gergen-s-orthodontic-lab)
- Steven B. Lamberg, Dds: 1 (https://510kreport.com/company/steven-b-lamberg-dds)
- Panthera Dental, Inc.: 1 (https://510kreport.com/company/panthera-dental)
- Sleeping Well, LLC: 1 (https://510kreport.com/company/sleeping-well)

## Its most-cited devices
- K050592: Somnomed Mas Rxa (2005), cited by 17
- K073004: Somnomed  Bflex (2008), cited by 8
- 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 (2015), cited by 5
- K102909: Somnobrux Splints (2011), cited by 3
- K121340: Somnodent G2 (2012), cited by 3
- K183443: SomnoDent Avant (2019), cited by 2

## Recent decisions
- K261366: Virtus (Jun 12, 2026)
- K233497: Rest Assure System (Oct 3, 2024)
- K183443: SomnoDent Avant (May 8, 2019)
- K162306: SomnoDent ALPHA (Sep 20, 2016)
- 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 (Jun 18, 2015)
- K140278: Somnodent Fusion, Classic; Somnodent Fusion, Flex (Jun 20, 2014)
- K130558: Somnodent Herbst; Classic, Flex (May 17, 2013)
- K121340: Somnodent G2 (May 30, 2012)

Source page: https://510kreport.com/company/somnomed