Manufacturer registered with FDA
TECNO-GAZ S.p.A.
SALA BAGANZA, Italy. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 648 registrations outside the US
- Establishments
- 1Italy
Registered in 6 markets
Where regulators' registries name TECNO-GAZ S.p.A. 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 | TECNO-GAZ S.p.A. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Tecno-Gaz S.p.A | 41 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Tecno-Gaz S.p.A. | 3 | 2016–2018 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TECNO-GAZ S.p.A. | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | TECNO - GAZ S.P.A. | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | TECNO GAZ S.p.A | 1 | — | 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 TECNO-GAZ S.p.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Swan-I | 2026 |
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 |
|---|---|---|
| TECNO-GAZ S.P.A.FDA reg. 3003922211 | SALA BAGANZA Parma, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095406). 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.