510(k) Report

FDA applicant

Sterilex Corp.

Owins Mills, MD1 decision1999–19990 recalls

FDA records 1 decision for Sterilex Corp. (Owins Mills, MD) in 1999: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). 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 Sterilex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterilex Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sterilex Corp. 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?

  • EIAUnit, Operative Dental1decision

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.

  • K991946Ultra-Kleen Powder for Dental Unit Water Lines, Models 513P, 505LSterilex Corp. · 19991cites it

What has FDA decided for it lately?

  • K991946Ultra-Kleen Powder for Dental Unit Water Lines, Models 513P, 505LSterilex Corp. · 1999

The one decision as Sterilex Corp. →