510(k) Report

FDA applicant

E&D Dental Products, Inc.

Westfield, NJ3 decisions1991–19950 recalls

FDA records 3 decisions for E&D Dental Products, Inc. (Westfield, NJ) from 1991 to 1995: 3 510(k) clearances. Most are in product codes EJB (Handle, Instrument, Dental) and EBH (Material, Impression Tray, Resin). 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 E&D Dental Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for E&D Dental Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — E&D Dental Products, 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?

  • EJBHandle, Instrument, Dental1decision
  • EBHMaterial, Impression Tray, Resin1decision
  • KLEAgent, Tooth Bonding, Resin1decision

What has FDA decided for it lately?

  • K953592Revolution BondE&D Dental Products, Inc. · 1995
  • K922633Cavi-ZymeE&D Dental Products, Inc. · 1992
  • K912820Polyester Resin Hand Molded TrayE&D Dental Products, Inc. · 1991

All 3 as E&D Dental Products, Inc. →