510(k) Report

FDA applicant

Instrumentations Unltd.

Quakertown, PA2 decisions1987–19910 recalls

FDA records 2 decisions for Instrumentations Unltd. (Quakertown, PA) from 1987 to 1991: 2 510(k) clearances. Most are in product codes DYX (Lock, Wire, And Ligature, Intraoral) and EGM (Injector, Jet, Mechanical-Powered). 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 Instrumentations Unltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instrumentations Unltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Instrumentations Unltd. 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?

  • DYXLock, Wire, And Ligature, Intraoral1decision
  • EGMInjector, Jet, Mechanical-Powered1decision

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.

  • K910090Dimac WiresInstrumentations Unltd. · 19911cites it

What has FDA decided for it lately?

  • K910090Dimac WiresInstrumentations Unltd. · 1991
  • K864861Instrumentations Unlimited Syringe SystemInstrumentations Unltd. · 1987

All 2 as Instrumentations Unltd. →