Manufacturer registered with FDA
Bialex Lab
Wichita Falls, TX, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Bialex Lab as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bialex Lab | 1 device types | — | Below |
| Peru | DIGEMID | Manufacturer | BIALEX LAB | 3 | 2022–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bialex Lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | BIALEX Lead Screen CheckELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIALEX LABFDA reg. 3021841051 | Wichita Falls, TX, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049801). 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.