Manufacturer registered with FDA
SDS Swiss Dental Solutions AG
Kreuzlingen, Switzerland. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 0
- 510(k) clearances
- 22019–2020
- Markets registered in
- 466 registrations outside the US
- Establishments
- 1Switzerland
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name SDS Swiss Dental Solutions AG 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 | SDS Swiss Dental Solutions AG | 2 clearances | 2019–2020 | Below |
| United Kingdom | MHRA | Manufacturer | SDS Swiss Dental Solutions AG | 32 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | SDS Swiss Dental Solutions AG | 22 | — | Pure Global AI |
| Australia | TGA | Manufacturer | SDS Swiss Dental Solutions AG | 12 | 2025–2025 | 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 SDS Swiss Dental Solutions AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2019 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | — | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | 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 |
|---|---|---|
| SDS SWISS DENTAL SOLUTIONSFDA reg. 3014540272 | Kreuzlingen Thurgau, Switzerland | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057971). 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.