Manufacturer registered with FDA
Industria Zingardi srl
Novi Ligure, Italy. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 48 registrations outside the US
- Establishments
- 1Italy
Registered in 4 markets
Where regulators' registries name Industria Zingardi srl 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 | Industria Zingardi srl | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | INDUSTRIA ZINGARDI S.R.L. | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | INDUSTRIA ZINGARDI S.r.lINDUSTRIA ZINGARDI srl | 2 | 2011–2011 | Pure Global AI |
| Canada | Health Canada | Registration holder | INDUSTRIA ZINGARDI S.R.L | 1 | 2025–2025 | 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 Industria Zingardi srl 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 Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | HydrosonicSamba | 2024 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Dental Floss | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | HydrosonicSamba | 2020 |
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 |
|---|---|---|
| INDUSTRIA ZINGARDI S.R.LFDA reg. 3008960188 | Novi Ligure Piedmont, Italy | Contract manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079706). 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.