A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking t
| Company | Devices | Share |
|---|---|---|
| The Myerson Company Limited | 93 | 18% |
| Leone Spa | 61 | 12% |
| Ema Sleep Incorporated | 44 | 9% |
| Selane Products, Inc. | 43 | 9% |
| Somnomed, Inc. | 38 | 8% |
| Advanced Brain Monitoring, Inc. | 32 | 6% |
| Modern Dental Laboratory (Dg) Co., Ltd. | 27 | 5% |
| Respire Medical Holdings Llc | 22 | 4% |
| Prismatik Dentalcraft, Inc | 17 | 3% |
| Ortho Solutions, Lc | 16 | 3% |
| Airway Technologies, Llc | 13 | 3% |
| Prosomnus Sleep Technologies | 11 | 2% |
Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| LRK | Device, Anti-Snoring | 406 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 61 |
| LQZ | Device, Jaw Repositioning | 54 |
| LRK | Device, anti-snoring | 20 |
| PLC | Sleep Appliances With Patient Monitoring | 13 |
| NSR | Prosthesis, Orthodontic | 9 |
Use these as the dimensions to specify in a tender line.
505 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mandible-repositioning sleep-disordered breathing orthosis", from 44 companies. The largest labeler is The Myerson Company Limited with 18% of records.
LRK (Device, Anti-Snoring), DYJ (Retainer, Screw Expansion, Orthodontic), LQZ (Device, Jaw Repositioning), LRK (Device, anti-snoring)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.