510(k) Report

FDA applicant

Gestenco International AB

Goteborg, SE1 decision2005–20050 recalls

FDA records 1 decision for Gestenco International AB (Goteborg, SE) in 2005: 1 510(k) clearance. All are in product code DYW (Bracket, Plastic, Orthodontic). 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 Gestenco International AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gestenco International AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gestenco International AB 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?

  • DYWBracket, Plastic, Orthodontic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K053055Orthodontic Polymer Composite BracketGestenco International AB · 20051cites it

What has FDA decided for it lately?

  • K053055Orthodontic Polymer Composite BracketGestenco International AB · 2005

The one decision as Gestenco International AB →