Manufacturer registered with FDA
Tecnodent S.R.L
Casalecchio di Reno, Italy. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 45 registrations outside the US
- Establishments
- 1Italy
Registered in 4 markets
Where regulators' registries name Tecnodent S.R.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 | Tecnodent S.R.L | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | TECNODENT S.R.L. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Tecnodent S.R.L | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | TECNODENT S.P.A | 1 | 2000–2000 | 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 Tecnodent S.R.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 |
|---|---|---|---|---|
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | LINDA EVOLINDA NEXTVALE | 2025 |
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 |
|---|---|---|
| TECNODENT SRLFDA reg. 9614505 | Casalecchio di Reno Bologna, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094329). 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.