510(k) Report

FDA applicant

Del Pharmaceuticals, Inc.

Uniondale, NY1 decision2004–20040 recalls

FDA records 1 decision for Del Pharmaceuticals, Inc. (Uniondale, NY) in 2004: 1 510(k) clearance. All are in product code KLE (Agent, Tooth Bonding, 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 Del Pharmaceuticals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Del Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Del Pharmaceuticals, 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?

  • KLEAgent, Tooth Bonding, Resin1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041680Orajel Advanced Tooth DesensitizerDel Pharmaceuticals, Inc. · 20043cite it

What has FDA decided for it lately?

  • K041680Orajel Advanced Tooth DesensitizerDel Pharmaceuticals, Inc. · 2004

The one decision as Del Pharmaceuticals, Inc. →