Manufacturer registered with FDA
3DIEMME Srl
Cantu, Italy. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 844 registrations outside the US
- Establishments
- 1Italy
Registered in 8 markets
Where regulators' registries name 3DIEMME 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 | 3DIEMME Srl | 2 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | 3DIEMME Srl | 17 | — | Pure Global AI |
| Australia | TGA | Manufacturer | 3DIEMME Srl | 11 | 2022–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | 3DIEMME srl | 8 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | 3DIEMME SRL | 4 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | 3Diemme S.r.l | 2 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | 3DIEMME SRL | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | 3DIEMME srl | 1 | 2015–2015 | 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 3DIEMME 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 |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | EVOBITE | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ANCHOR PINSBONE CREST LEVELERDRILLDRILL BITMOUTH OPENING GAUGERealGUIDE IMPLANT MOUNTRealGUIDE SLEEVESQUARE CONNECTOR FOR HANDPIECETISSUE PUNCHTORQUE WRENCH EXTENSION | 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 |
|---|---|---|
| 3DIEMME SRLFDA reg. 3015173183 | Cantu Como, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059505). 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.