Manufacturer registered with FDA
FARO S.p.A.
Ornago (MB), Italy. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 312 registrations outside the US
- Establishments
- 1Italy
Registered in 3 markets
Where regulators' registries name FARO 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 | FARO S.p.A. | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | FARO S.P.A.FARO | 10 | 2006–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | FARO S.p.A.Faro S.P.A | 2 | — | 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 FARO 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 |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | E72EDI S ULEDI TS ULEVAMAIA LED LIGHTTESTATA MAIA USA | 2003 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | SYR 3SYR 6 | 2005 |
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 |
|---|---|---|
| FARO S.P.A.FDA reg. 3004187094 | Ornago (MB) Milano, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059184). 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.