Data / Medical devices / Germany / DMG Digital Enterprises Se
DMG Digital Enterprises Se: FDA-registered device maker in Hamburg, Germany, 1 510(k) clearance
DMG Digital Enterprises Se is registered with the FDA (registration 3012623144) in Hamburg, Germany. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012623144
- Address
- Elbgaustrasse 248, Hamburg, Germany, 22547
- Owner or operator
- DMG Digital Enterprises SE (10079030)
- Roles
- Manufacturer
- First device listed
- November 16, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 3, 2021 | K210940 | LuxaPrint Ortho Plus | MQC | Substantially Equivalent | Dmg Digital Enterprises SE | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Maintainer, Space Preformed, Orthodontic
- All makers of Indirect Bonding Tray
- All makers of Material, Impression Tray, Resin
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Mouthguard, Prescription
Updated September 3, 2021. 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.