Manufacturer registered with FDA
TRI Dental Implants Int. AG
Hünenberg, Switzerland. Lists 3 dental device types with FDA across 2 registered establishments, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 32015–2025
- Markets registered in
- 8106 registrations outside the US
- Establishments
- 2Switzerland, Germany
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name TRI Dental Implants Int. AG 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 | TRI Dental Implants Int. AG | 3 clearances | 2015–2025 | Below |
| Saudi Arabia | SFDA | Manufacturer | TRI Dental Implants Int. AG | 73 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | TRI Dental Implants Int. AG, | 9 | 2022–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TRI Dental Implants Int. AG | 8 | — | Pure Global AI |
| Australia | TGA | Manufacturer | TRI Dental Implants Int AG | 6 | 2014–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | TRI Dental Implants Int. AG | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | TRI Dental Implants Int. AG | 4 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TRI Dental Implants Int. AG | 1 | 2014–2014 | 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 TRI Dental Implants Int. AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | TRI Dental Implant SystemTRI Matrix X-ForceTRI-matrix Implant Line | 2016 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | TRI Dental Implant SystemTRI-matrix Implant Line | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | TRI Dental Implant Systems Instruments and Accessories | 2016 |
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 TRI Dental Implants Int. AG as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TRI Dental Implants Direct GmbHFDA reg. 3010303805 | Freiburg Baden-Wurttemberg, Germany | Foreign exporter |
| TRI DENTAL IMPLANTS INT. AGFDA reg. 3012172055 | Huenenberg Zug, Switzerland | Manufacturer |
Other names on FDA records
TRI Dental Implants Direct GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051641). 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.