510(k) Report

FDA applicant

Lumendo AG

Renens, CH2 decisions2023–20230 recalls

FDA records 2 decisions for Lumendo AG (Renens, CH) in 2023: 2 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and QNF (Laser Activator For Polymerization). 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 Lumendo AG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Lumendo AG by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KIFResin, Root Canal Filling1decision
  • QNFLaser Activator For Polymerization1decision

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?

All 2 as Lumendo AG →