510(k) Report

FDA applicant

Karolinski

Stockholm, SE1 decision1997–19970 recalls

FDA records 1 decision for Karolinski (Stockholm, SE) in 1997: 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 Karolinski’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Karolinski since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Karolinski 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

What has FDA decided for it lately?

  • K970246Edta CavitKarolinski · 1997

The one decision as Karolinski →