Manufacturer registered with FDA
Nichrominox SA
SAINT BONNET DE MURE, France. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 521 registrations outside the US
- Establishments
- 1France
Registered in 5 markets
Where regulators' registries name Nichrominox SA 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 | Nichrominox SA | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | NICHROMINOX | 10 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Nichrominox SANICHROMINOX | 6 | 2023–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | NICHROMINOX | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NICHROMINOX | 1 | 2009–2009 | 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 Nichrominox SA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | — | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2017 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | — | 2019 |
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 |
|---|---|---|
| NICHROMINOXFDA reg. 3008519369 | SAINT BONNET DE MURE Rhone, France | Contract manufacturer, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044242). 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.