Data / Medical devices / Germany / Orangecad Med GMBH
Orangecad Med GMBH: FDA-registered device maker in Karlsruhe Baden-Wurttemberg, Germany, 1 510(k) clearance
Orangecad Med GMBH is registered with the FDA (registration 3030488649) in Karlsruhe Baden-Wurttemberg, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030488649
- Address
- Emmy-Noether-Str. 11, Karlsruhe Baden-Wurttemberg, Germany, 76131
- Owner or operator
- OrangeCAD Med GmbH (10090072)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 12, 2024
- Registered through
- 2026
- Brand names listed
- Dental Implant Accesories, OrangeCAD Med Abutments
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| December 23, 2025 | K253312 | OrangeCAD Med Abutments | NHA | Substantially Equivalent | Orangecad Med GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated December 23, 2025. 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.