Manufacturer registered with FDA
Software Nemotec, S.L.
Leganés, Spain. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 22020–2023
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Software Nemotec, S.L. 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 | Software Nemotec, S.L. | 2 clearances | 2020–2023 | Below |
| European Union | EUDAMED | Manufacturer | Software Nemotec S.L. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SOFTWARE NEMOTEC, S.L. | 1 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Software NemoTec S.L. | 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 Software Nemotec, S.L. 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 SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | NemoCast | 2020 |
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 |
|---|---|---|
| SOFTWARE NEMOTEC, S.L.FDA reg. 3016446349 | Leganes Madrid(Province), Spain | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062432). 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.