510(k) Report

FDA applicant

Harald Nordin S.A

Concord, MA3 decisions1994–20000 recalls

FDA records 3 decisions for Harald Nordin S.A (Concord, MA) from 1994 to 2000: 3 510(k) clearances. All are in product code ELR (Post, Root Canal). 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 Harald Nordin S.A’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harald Nordin S.A since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Harald Nordin S.A 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?

  • ELRPost, Root Canal3decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K003221Harald Nordin Glassix Glass Fiber Composite Dental PostHarald Nordin S.A · 20002cite it

What has FDA decided for it lately?

  • K003221Harald Nordin Glassix Glass Fiber Composite Dental PostHarald Nordin S.A · 2000
  • K003219Harald Nordin Carbonite Carbon Fiber Composite Dental PostHarald Nordin S.A · 2000
  • K931396Dental Screw PostsHarald Nordin S.A · 1994

All 3 as Harald Nordin S.A →