510(k) Report

FDA applicant

Sultan Dental Products, Ltd.

Englewood, NJ1 decision2000–20000 recalls

FDA records 1 decision for Sultan Dental Products, Ltd. (Englewood, NJ) in 2000: 1 510(k) clearance. All are in product code LBH (Varnish, Cavity). 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 Sultan Dental Products, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sultan Dental Products, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sultan Dental Products, Ltd. 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?

  • LBHVarnish, Cavity1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K002581Duragard Sodium Fluoride VarnishSultan Dental Products, Ltd. · 20001cites it

What has FDA decided for it lately?

  • K002581Duragard Sodium Fluoride VarnishSultan Dental Products, Ltd. · 2000

The one decision as Sultan Dental Products, Ltd. →

Other applicant names beginning “Sultan”

FDA records each applicant name separately; these may or may not be the same firm.

Sultan Chemists, Inc. 11