Manufacturer registered with FDA
Oniris
RUEIL MALMAISON, France. 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
- 2
- 510(k) clearances
- 12025–2025
- Markets registered in
- 79 registrations outside the US
- Establishments
- 1France
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Oniris 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 | Oniris | 1 clearances | 2025–2025 | Below |
| Colombia | INVIMA | Registration holder | ONIRIS | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Oniris | 1 | 2019–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ONIRIS | 1 | 2018–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | oniris | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | ONIRIS | 1 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | ONIRIS | 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 Oniris 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 | Oniris PlusONIRIS Pro | 2017 |
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
Oniris 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: Sas Oniris (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Mar 2016 | K150566 | Oniris | Sas Oniris | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ONIRISFDA reg. 3013548547 | RUEIL MALMAISON Hauts-de-Seine, France | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054416). 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.