A removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tis
| Company | Devices | Share |
|---|---|---|
| Island Dental Lab Inc. Dba Emerald Dental Lab | 141 | 91% |
| Apex Dental Sleep Lab Incorporated | 5 | 3% |
| Braebon Medical Corporation | 4 | 3% |
| Crane Dental Laboratory, Inc. | 2 | 1% |
| Slow Wave, Inc. | 2 | 1% |
| Allesee Aoa-Pro | 1 | 1% |
Company = labeler of record on GUDID. 6 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 | 150 |
| LQZ | Device, Jaw Repositioning | 148 |
Use these as the dimensions to specify in a tender line.
155 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis", from 6 companies. The largest labeler is Island Dental Lab Inc. Dba Emerald Dental Lab with 91% of records.
LRK (Device, Anti-Snoring), LQZ (Device, Jaw Repositioning)
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.