Data / Medical devices / Italy / Dental Manufacturing SPA
Dental Manufacturing SPA: FDA-registered device maker in Badia Polesine Rovigo, Italy, 4 510(k) clearances
Dental Manufacturing SPA is registered with the FDA (registration 3001389926) in Badia Polesine Rovigo, Italy. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001389926
- Address
- Via Ca Mignola Nuova, 1699, Badia Polesine Rovigo, Italy, 45021
- Owner or operator
- DENTAL MANUFACTURING SPA (10061948)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 5, 2019
- Registered through
- 2026
- Brand names listed
- ACRY NATURE AFG 6 LOWER, ACRY NATURE AFG 6 UPPER, ACRY NATURE AFG 8 LOWER, ACRY NATURE AFG 8 UPPER, ACRY PLUS, ACRY PLUS V, ACRY PRINT 3D RU-001 TEMPORARY, ACRY PRINT 3D RU-003 TRY-IN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Long-Term Temporary, Resin | POW | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Exporter to the US | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Exporter to the US | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Exporter to the US | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 5, 2026 | K261456 | Ruthinium Disc | POW | Substantially Equivalent | Dental Manufacturing S.p.A. | accessdata.fda.gov |
| October 21, 2021 | K211415 | GR Splint Resin System | MQC | Substantially Equivalent | Pro3Dure Medical GmbH | accessdata.fda.gov |
| May 5, 2021 | K210298 | GR-14 Resin System | EBI | Substantially Equivalent | Pro3Dure Medical GmbH | accessdata.fda.gov |
| November 5, 2020 | K201827 | GR-17 Resin System | EBG | Substantially Equivalent | Pro3Dure Medical GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Positioner, Tooth, Preformed
- All makers of Mouthguard, Prescription
- All makers of Plate, Base, Shellac
Updated August 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.