Manufacturer registered with FDA
Biolux Technology GmbH
Absdorf, Austria. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 12023–2023
- Markets registered in
- 55 registrations outside the US
- Establishments
- 1Austria
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Biolux Technology GmbH 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 | Biolux Technology GmbH | 1 clearances | 2023–2023 | Below |
| European Union | EUDAMED | Manufacturer | Biolux Technology GmbH | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Biolux Technology GmbH | 1 | 2022–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Biolux Technology GmbH | 1 | 2020–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Biolux Technology GmbH | 1 | — | 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 Biolux Technology GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Led AccessoryPLH · Class 2 | — | Maker | OrthoPulseOrthoPulse - Extended - Gen 2OrthoPulse - Standard - Gen 2OrthoPulse Lite | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Biolux Technology GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Biolux Research , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Jul 2015 | K143120 | OrthoPulse | Biolux Research , Ltd. | PLH Orthodontic Led Accessory |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOLUX TECHNOLOGY GMBHFDA reg. 3017271131 | Absdorf Niederosterreich, Austria | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049976). 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.