510(k) Report

FDA applicant

Berkley and Co.

Spirit Lake, IA3 decisions1984–19850 recalls

FDA records 3 decisions for Berkley and Co. (Spirit Lake, IA) from 1984 to 1985: 3 510(k) clearances. Most are in product codes DZC (Wire, Orthodontic) and GAA (Needle, Aspiration And Injection, Disposable). 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 Berkley and Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Berkley and Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Berkley and Co. 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?

  • DZCWire, Orthodontic2decisions
  • GAANeedle, Aspiration And Injection, Disposable1decision

What has FDA decided for it lately?

  • K854579Hypodermic Needle and StyletBerkley and Co. · 1985
  • K843171Filafex TM, Esthetic Orthodontic WireBerkley and Co. · 1984
  • K833788Filafex Esthetic Orthodinic WireBerkley and Co. · 1984

All 3 as Berkley and Co. →

Other applicant names beginning “Berkley”

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

Berkley Medical Resources, Inc. 2