510(k) Report

FDA applicant

Amdent AB

Nynashamn, SE1 decision1993–19930 recalls

FDA records 1 decision for Amdent AB (Nynashamn, SE) in 1993: 1 510(k) clearance. All are in product code ELC (Scaler, Ultrasonic). 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 Amdent AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Amdent AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Amdent 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?

  • ELCScaler, Ultrasonic1decision

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.

  • K920328Amdent 2030, Polisher/ScalerAmdent AB · 19931cites it

What has FDA decided for it lately?

  • K920328Amdent 2030, Polisher/ScalerAmdent AB · 1993

The one decision as Amdent AB →