Manufacturer registered with FDA
Dental Manufacturing S.p.A.
Badia Polesine, Italy. Lists 6 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 6
- Brands and models
- 23
- 510(k) clearances
- 12026–2026
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Dental Manufacturing S.p.A. 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 | Dental Manufacturing S.p.A. | 1 clearances | 2026–2026 | Below |
| European Union | EUDAMED | Registration holder | DENTAL MANUFACTURING S.P.A | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTAL MANUFACTURING S.P.A. | 1 | 2006–2006 | 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 Dental Manufacturing S.p.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | ACRY PRINT 3D RU-001 TEMPORARYRUTHINIUM DISCRUTHINIUM DISC MULTILAYERRUTHINIUM DISC MULTILAYER SC | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | ACRY PRINT 3D RU-004 DENTURE HIACRY PRINT 3D RU-005 GUIDE | 2025 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | ACRY NATURE AFG 6 LOWERACRY NATURE AFG 6 UPPERACRY NATURE AFG 8 LOWERACRY NATURE AFG 8 UPPERACRY PLUSACRY PLUS VACRY PRINT 3D RU-001 TEMPORARYACRY SMARTACRY SMART DIGITAL 6 LOWERACRY SMART DIGITAL 6 UPPER 2 moreACRY SMART DIGITAL 8 LOWERACRY SMART DIGITAL 8 UPPER | 2019 |
| Shellac Base PlateEEA · Class 1 | — | Lister | ACRY PRINT 3D RU-003 TRY-IN | 2025 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | ACRY PRINT 3D RU-005 GUIDE | 2025 |
| Resin Long-Term Temporary Crown and BridgePOW · Class 2 | — | Maker | RUTHINIUM DISCRUTHINIUM DISC MULTILAYERRUTHINIUM DISC MULTILAYER SC | 2026 |
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
Dental Manufacturing S.p.A. 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: pro3dure medical GmbH (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 May 2021 | K210298 | GR-14 Resin System | pro3dure medical GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 5 Nov 2020 | K201827 | GR-17 Resin System | pro3dure medical GmbH | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTAL MANUFACTURING SPAFDA reg. 3001389926 | Badia Polesine Rovigo, Italy | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061948). 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.