510(k) Report

FDA applicant

Unisplint Corp.

Mchenry, IL2 decisions1982–19830 recalls

FDA records 2 decisions for Unisplint Corp. (Mchenry, IL) from 1982 to 1983: 2 510(k) clearances. Most are in product codes GEO (File, Surgical, General & Plastic Surgery) and DYX (Lock, Wire, And Ligature, Intraoral). 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, general and plastic surgery panel, where it files most

How often FDA has decided Unisplint Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Unisplint Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Unisplint 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?

  • GEOFile, Surgical, General & Plastic Surgery1decision
  • DYXLock, Wire, And Ligature, Intraoral1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K820944Dental Arch BarUnisplint Corp. · 19824cite it

What has FDA decided for it lately?

  • K830675Oral SpongeUnisplint Corp. · 1983
  • K820944Dental Arch BarUnisplint Corp. · 1982

All 2 as Unisplint Corp. →