Manufacturer registered with FDA
pro3dure medical GmbH
Iserlohn, Germany. Lists 8 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 49
- 510(k) clearances
- 22020–2021
- Markets registered in
- 646 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name pro3dure medical GmbH 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 | pro3dure medical GmbH | 2 clearances | 2020–2021 | Below |
| European Union | EUDAMED | Manufacturer | pro3dure medical GmbH | 24 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | PRO3DURE MEDICAL GMBH | 13 | 2021–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | pro3dure medical GmbH | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PRO3DURE MEDICAL GMBH | 2 | 2022–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | pro3dure medical GmbH | 1 | 2022–2022 | 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 pro3dure medical GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | ACRY Print RU-004 Denture HIACRY Print RU-005 Guidedima Print Denture Base 2dima Print Splint clearFLOW DentureFLOW Hard SplintGR-10 guideGR-14.1 dentureGR-14.2 denture HIGR-19 OA 4 moreGR-20 MJFGR-22 flexSTRUCTOMER SPLINTUCAN Print Base | 2021 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | ACRY Print RU-005 Guidedima Print Splint clearFLOW Hard SplintGR-10 guideGR-10 guide I MSIGR-19 OAGR-19.1 OAGR-19.1 OA I MSIGR-20 MJFGR-22 flex 2 moreSTRUCTOMER SPLINTUCAN Print Splint | 2021 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | GR-16 x-rayGR-19.1 OAGR-19.1 OA I MSIImprimo LC Splint comfortImprimo LC Splint comfort MSI | 2019 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | ACRY Print RU-001 temporaryFLOW C&BGR-17 temporaryGR-17.1 temporary lt; Structomer Temps | 2020 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | GR-11 Tray;GR-18.1 IB;STRUCTOMER IBTGR-11.1 TrayGR-16 XrayGR-18.2 IBUCAN Print Tray | 2019 |
| Shellac Base PlateEEA · Class 1 | — | Maker | ACRY Print RU-003 Try-InGR-21 Try-InGR-21.1 Try-InUCAN Print Try-In | 2019 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | GR-1 Guide | 2019 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | ACRY Print RU-001 temporaryFLOW C&BGR-17 temporaryGR-17.1 temporary lt; Structomer Temps | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names pro3dure medical GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 May 2021 | K210298 | GR-14 Resin System | EBI Rebasing Repairing Relining Denture Resin |
| 5 Nov 2020 | K201827 | GR-17 Resin System | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Dental Manufacturing S.p.A. (2), Kulzer, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRO3DURE MEDICAL GMBHFDA reg. 3014888923 | Iserlohn North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059691). 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.