510(k) Report

FDA applicant

Karolinska Institutet

Potomac, MD1 decision1994–19940 recalls

FDA records 1 decision for Karolinska Institutet (Potomac, MD) in 1994: 1 510(k) clearance. All are in product code EBF (Material, Tooth Shade, Resin). 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 Karolinska Institutet’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karolinska Institutet since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Karolinska Institutet 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?

  • EBFMaterial, Tooth Shade, Resin1decision

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.

  • K940737Edta Gel (TM)Karolinska Institutet · 19941cites it

What has FDA decided for it lately?

  • K940737Edta Gel (TM)Karolinska Institutet · 1994

The one decision as Karolinska Institutet →