Manufacturer registered with FDA
DMG Digital Enterprises SE
Hamburg, Germany. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 26 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name DMG Digital Enterprises SE 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 | DMG Digital Enterprises SE | 5 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | DMG Digital Enterprises SE | 6 | — | 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 DMG Digital Enterprises SE currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | — | 2020 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | — | 2020 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | — | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2020 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | — | 2021 |
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 |
|---|---|---|
| DMG DIGITAL ENTERPRISES SEFDA reg. 3012623144 | Hamburg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079030). 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.