Manufacturer registered with FDA
VANNINI DENTAL INDUSTRY S.r.l.
GRASSINA, 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
- 619 registrations outside the US
- Establishments
- 1Italy
Registered in 6 markets
Where regulators' registries name VANNINI DENTAL INDUSTRY S.r.l. 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 | VANNINI DENTAL INDUSTRY S.r.l. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | VANNINI DENTAL INDUSTRY S.R.L | 7 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | VANNINI DENTAL INDUSTRY S.r.l. | 6 | 2024–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | VANNINI DENTAL INDUSTRY S.R.L | 4 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | VANNINI DENTAL INDUSTRY S.r.l. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | VANNINI DENTAL INDUSTRY S.R.L. | 1 | 2026–2026 | 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 VANNINI DENTAL INDUSTRY 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 |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | Cromatic | 2014 |
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
VANNINI DENTAL INDUSTRY 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: Dentsply Sirona, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Nov 1996 | K963609 | PHASE PLUS | Dentsply Sirona, Inc. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| VANNINI DENTAL INDUSTRY SRLFDA reg. 8021038 | GRASSINA(FI) Firenze, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8021038). 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.