510(k) Report

FDA applicant

Trinon Titanium GmbH

Tuttlingen, DE2 decisions2012–20170 recalls

FDA records 2 decisions for Trinon Titanium GmbH (Tuttlingen, DE) from 2012 to 2017: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 5 predicates, 0 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 Trinon Titanium GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2012: 12017: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Trinon Titanium GmbH by year, 2012–2026Sources: 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-Form2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH · 2017
  • K103577Trinon Q & Q3 Implant SystemTrinon Titanium GmbH · 2012

All 2 as Trinon Titanium GmbH →