Manufacturer registered with FDA
EMA-Sleep Inc
Bastrop, TX, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What EMA-Sleep Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | EMA 3D | 2025 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | EMA 3D | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names EMA-Sleep Inc as the applicant.
Some of these clearances are listed with FDA today by another company: Burbank Dental Lab (1), Apex Dental Sleep Lab (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EMA-SLEEP INCFDA reg. 3039643908 | Bastrop, TX, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093941). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.