510(k) Report

FDA applicant

Denfotex Light Systems, Ltd.

Inverkeithing Fife, Scotland, GB1 decision2004–20040 recalls

FDA records 1 decision for Denfotex Light Systems, Ltd. (Inverkeithing Fife, Scotland, GB) in 2004: 1 510(k) clearance. All are in product code EBZ (Activator, Ultraviolet, For Polymerization). 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 Denfotex Light Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Denfotex Light Systems, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Denfotex Light Systems, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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