510(k) Report

FDA applicant

3M Espe AG

Bavaria D-82228 Seefeld, DE6 decisions2011–20140 recalls

FDA records 6 decisions for 3M Espe AG (Bavaria D-82228 Seefeld, DE) from 2011 to 2014: 6 510(k) clearances. Most are in product codes ELW (Material, Impression) and EIH (Powder, Porcelain). Its devices cite 12 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 3M Espe AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2011: 32012: 12014: 2
2011high 3 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — 3M Espe AG by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELWMaterial, Impression2decisions
  • EIHPowder, Porcelain2decisions
  • KLEAgent, Tooth Bonding, Resin1decision
  • EMACement, Dental1decision

Whose devices does it build on?

Its devices cite 12 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 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.

  • K110302Adhesive Exl-7593M Espe AG · 201115cite it
  • K110508Suglue-103M Espe AG · 20113cite it
  • K111257Heisenberg Dyeing Liquids3M Espe AG · 20111cites it
  • K120011Heisenberg Effect Shades3M Espe AG · 20121cites it

What has FDA decided for it lately?

  • K140602Flash Penta MB Quick, Flash MB Quick3M Espe AG · 2014
  • K133400Flash Bite3M Espe AG · 2014
  • K120011Heisenberg Effect Shades3M Espe AG · 2012
  • K110508Suglue-103M Espe AG · 2011
  • K110302Adhesive Exl-7593M Espe AG · 2011
  • K111257Heisenberg Dyeing Liquids3M Espe AG · 2011

All 6 as 3M Espe AG →