Manufacturer registered with FDA
Curaden AG
Kriens, Switzerland. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 3132 registrations outside the US
- Establishments
- 1Switzerland
Registered in 3 markets
Where regulators' registries name Curaden 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 | Curaden AG | 5 device types | — | Below |
| Colombia | INVIMA | Manufacturer | CURADEN AG | 131 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CURADEN AG | 1 | 2016–2016 | 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 Curaden 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Curaprox | 2008 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Power Duo | 2008 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Hydrosonic PRO | 2018 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Curaprox Dental Floss | 2021 |
| Teething Ring Non-Fluid FilledMEF · Class 1 | — | Maker | Curaprox Baby | 2008 |
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 |
|---|---|---|
| CURADEN AGFDA reg. 3007113231 | Kriens Luzern, Switzerland | Foreign exporter, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10026593). 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.