Data / Medical devices / Germany / TRI Dental Implants Direct GmbH
TRI Dental Implants Direct GmbH: FDA-registered device maker in Freiburg Baden-Wurttemberg, Germany, 3 510(k) clearances
TRI Dental Implants Direct GmbH is registered with the FDA (registration 3010303805) in Freiburg Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010303805
- Address
- Merzhauserstrasse 183, Freiburg Baden-Wurttemberg, Germany, 79100
- Owner or operator
- TRI Dental Implants Int. AG (10051641)
- Roles
- Exporter to the US
- First device listed
- April 15, 2016
- Registered through
- 2026
- Brand names listed
- TRI Dental Implant System, TRI Dental Implant Systems Instruments and Accessories, TRI Matrix X-Force, TRI-matrix Implant Line
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Exporter to the US | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 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 |
|---|---|---|---|---|---|---|
| January 8, 2025 | K242661 | TRI-matrix® X-Force Implants | DZE | Substantially Equivalent | Tri Dental Implants Int. AG | accessdata.fda.gov |
| December 21, 2021 | K203660 | TRI-matrix Implant Line | DZE | Substantially Equivalent | Tri Dental Implants Int. AG | accessdata.fda.gov |
| December 18, 2015 | K151916 | TRI Dental Implant System | DZE | Substantially Equivalent | Tri Dental Implants Int. AG | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated January 8, 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.