Manufacturer registered with FDA
I-Dent Innovations for Dentistry SA
Nyon, Switzerland. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1Switzerland
Registered in 3 markets
Where regulators' registries name I-Dent Innovations for Dentistry 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 | I-Dent Innovations for Dentistry SA | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | I-Dent Innovations for Dentistry SA | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | I-DENT INNOVATIONS FOR DENTISTRY SA | 2 | 2007–2018 | 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 I-Dent Innovations for Dentistry 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 |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | — | 2017 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Ever clear II | 2016 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | — | 2023 |
| Light Transmission Caries DetectorNTK · Class 2 | Caries detection devices | Maker | — | 2023 |
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 |
|---|---|---|
| I-DENT INNOVATIONS FOR DENTISTRY SAFDA reg. 3007113232 | Nyon Vaud, Switzerland | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053667). 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.