Manufacturer registered with FDA
Edenta Etablissement
SCHAANWALD, Liechtenstein. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8111 registrations outside the US
- Establishments
- 1Liechtenstein
Registered in 8 markets
Where regulators' registries name Edenta Etablissement 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 | Edenta Etablissement | 6 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | Edenta Etablissement | 40 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Edenta Etablissement | 34 | 2024–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Edenta Etablissement | 21 | 2005–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Edenta Etablissement | 10 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | EDENTA ETABLISSEMENT | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EDENTA ETABLISSEMENT | 2 | 2017–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EDENTA ETABLISSEMENT | 1 | 2019–2019 | 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 Edenta Etablissement currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | ACHROMATNTI | 2006 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | NTI | 2006 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | AND ACCESSORY INSTRUMENTSPINRETENTIVE AND SPLINTING | 2001 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | CERAGLAZEDIAGLOSS AND PDQNTI | 2006 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | DIAMOND + CARBIDE BURSTC CUTTERS | 2001 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | POLISHERS | 2001 |
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 |
|---|---|---|
| EDENTA ETABLISSEMENTFDA reg. 3003399707 | SCHAANWALD Mauren, Liechtenstein | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9046099). 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.