510(k) Report

FDA applicant

Procordia Oratech AB

Huddinge, Sweden, SE1 decision1993–19930 recalls

FDA records 1 decision for Procordia Oratech AB (Huddinge, Sweden, SE) in 1993: 1 510(k) clearance. All are in product code NPK (Barrier, Synthetic, Intraoral). 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 Procordia Oratech AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Procordia Oratech AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Procordia Oratech 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?

  • NPKBarrier, Synthetic, Intraoral1decision

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.

  • K912724Guidor (TM)Procordia Oratech AB · 19931cites it

What has FDA decided for it lately?

  • K912724Guidor (TM)Procordia Oratech AB · 1993

The one decision as Procordia Oratech AB →