510(k) Report

FDA applicant

Z-Systems AG

Oensingen, CH9 decisions2007–20210 recalls

FDA records 9 decisions for Z-Systems AG (Oensingen, CH) from 2007 to 2021: 9 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 250 days from receipt to decision, against 230 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 12 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 Z-Systems AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12012: 12013: 12014: 12015: 12020: 32021: 1
2007high 3 (2020) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Z-Systems AG by year, 2007–2026Sources: 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-Form8decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 250 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 230 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 12 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.

  • K062542Z-LOOK3 Dental Implant System, Model Z3-XXXZ-Systems AG · 20076cite it
  • K120793Z-LOOK3 Evo SLMZ-Systems AG · 20125cite it
  • K132881Z5CZ-Systems AG · 20144cite it
  • K190243Z5-BLZ-Systems AG · 20202cite it
  • K201878ST-Z5Z-Systems AG · 20212cite it
  • K131701Z5MLB, Z5MLCZ-Systems AG · 20131cites it

What has FDA decided for it lately?

All 9 as Z-Systems AG →