510(k) Report

FDA applicant

Lysta A/S

Farum, DK2 decisions1999–19990 recalls

FDA records 2 decisions for Lysta A/S (Farum, DK) in 1999: 2 510(k) clearances. All are in product code EBZ (Activator, Ultraviolet, For Polymerization). Its devices cite 1 predicate, 1 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 Lysta A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lysta A/S since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lysta A/S 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?

  • EBZActivator, Ultraviolet, For Polymerization2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991138Lysta LC Curing Light, Model LC 2500C/BALysta A/S · 19991cites it

What has FDA decided for it lately?

  • K992236Lysta LC Compacta Curing Light, Models LC 2500 Compacta, LC 4000 Compacta, LC 6000 Compacta & LC 8000 CompatcaLysta A/S · 1999
  • K991138Lysta LC Curing Light, Model LC 2500C/BALysta A/S · 1999

All 2 as Lysta A/S →