Registered with FDA
Nuvola World S.R.L.
vicenza, Italy. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Italy
Devices listed with FDA
What Nuvola World 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 |
|---|---|---|---|---|
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | FREEDOMFreedom Deep | 2022 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Lister | NUVOLA | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Nuvola World S.R.L. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Gruppo Europeo Ortodonzia Srl (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Oct 2022 | K222418 | Nuvola | Gruppo Europeo Ortodonzia Srl | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NUVOLA WORLD S.R.L.FDA reg. 3025029555 | vicenza, Italy | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086506). 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.