510(k) Report

FDA applicant

Tri Dental Implants Int. AG

Huenenberg, CH3 decisions2015–20250 recalls

FDA records 3 decisions for Tri Dental Implants Int. AG (Huenenberg, CH) from 2015 to 2025: 3 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Tri Dental Implants Int. AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12021: 12025: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Tri Dental Implants Int. AG by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203660TRI-matrix Implant LineTri Dental Implants Int. AG · 20213cite it
  • K151916TRI Dental Implant SystemTri Dental Implants Int. AG · 20151cites it

What has FDA decided for it lately?

  • K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG · 2025
  • K203660TRI-matrix Implant LineTri Dental Implants Int. AG · 2021
  • K151916TRI Dental Implant SystemTri Dental Implants Int. AG · 2015

All 3 as Tri Dental Implants Int. AG →