510(k) Report

FDA applicant

Fen Dental Mfg., Inc.

Chicago, IL3 decisions1994–19960 recalls

FDA records 3 decisions for Fen Dental Mfg., Inc. (Chicago, IL) from 1994 to 1996: 3 510(k) clearances. Most are in product codes EBZ (Activator, Ultraviolet, For Polymerization) and ELW (Material, Impression). 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 Fen Dental Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fen Dental Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fen Dental Mfg., Inc. 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 Polymerization1decision
  • ELWMaterial, Impression1decision
  • EJJAlloy, Amalgam1decision

What has FDA decided for it lately?

  • K964323Chromoprint Chromatic Alginate Impression MaterialFen Dental Mfg., Inc. · 1996
  • K951465Sunlite 1275Fen Dental Mfg., Inc. · 1995
  • K942430Agalloy, Disalloy, Epsilon and LambdaFen Dental Mfg., Inc. · 1994

All 3 as Fen Dental Mfg., Inc. →