510(k) Report

FDA applicant

Euroteknika

Montreal, Quebec, CA3 decisions2009–20250 recalls

FDA records 3 decisions for Euroteknika (Montreal, Quebec, CA) from 2009 to 2025: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 14 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 Euroteknika’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 22025: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Euroteknika by year, 2009–2026Sources: 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
  • NHAAbutment, Implant, Dental, Endosseous1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K232383iPhysio® SystemEuroteknika · 2025
  • K083670Universal, Aesthetica, Natea, NaturaEuroteknika · 2009
  • K083669OBIEuroteknika · 2009

All 3 as Euroteknika →