Manufacturer registered with FDA
Luzzani Dental srl
Senago, Italy. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 56 registrations outside the US
- Establishments
- 1Italy
Registered in 5 markets
Where regulators' registries name Luzzani Dental 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 | Luzzani Dental srl | 1 device types | — | Below |
| Australia | TGA | Manufacturer | LUZZANI DENTAL SRL | 2 | 2024–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | LUZZANI DENTAL SRL | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Luzzani Dental SRL | 1 | 2003–2003 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Luzzani Dental S.r.l. | 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 Luzzani Dental 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 |
|---|---|---|---|---|
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | CGSMMGSG MINIMATE CG SYRINGE, ANGLEDCGSMMSSG MINIMATE CG SYRINGE, STRAIGHTSB3SSG MINIBRIGHT SYRINGE 3F, STRAIGHTSB6GSG MINIBRIGHT SYRINGE 3F, ANGLEDSB6GSG MINIBRIGHT SYRINGE 6F, ANGLEDSB6SSG MINIBRIGHT SYRINGE 6F, STRAIGHTSL3GASG MINILIGHT SYRINGE 3F, ANGLEDSL3SASG MINILIGHT SYRINGE 3F, STRAIGHTSL6GASG MINILIGHT SYRINGE 6F, ANGLEDSL6SASG MINILIGHT SYRINGE 6F, STRAIGHT 2 moreSMMGSG MINIMATE SYRINGE, ANGLEDSMMSSG MINIMATE SYRINGE, STRAIGHT | 2014 |
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 |
|---|---|---|
| LUZZANI DENTAL SRLFDA reg. 3010057414 | Senago Milano, Italy | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048146). 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.