510(k) Report

FDA applicant

Nordiska Dental AB

Lynwood, WA4 decisions1999–20000 recalls

FDA records 4 decisions for Nordiska Dental AB (Lynwood, WA) from 1999 to 2000: 4 510(k) clearances. Most are in product codes EJJ (Alloy, Amalgam) and EIH (Powder, Porcelain). Its devices cite 3 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 Nordiska Dental AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nordiska Dental AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nordiska Dental 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?

  • EJJAlloy, Amalgam3decisions
  • EIHPowder, Porcelain1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K002808Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyNordiska Dental AB · 2000
  • K002811Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyNordiska Dental AB · 2000
  • K002810Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyNordiska Dental AB · 2000
  • K992161CeranaNordiska Dental AB · 1999

All 4 as Nordiska Dental AB →