510(k) Report

FDA applicant

American Safety Equipment Corp.

Mchenry, IL7 decisions1976–19800 recalls

FDA records 7 decisions for American Safety Equipment Corp. (Mchenry, IL) from 1976 to 1980: 7 510(k) clearances. Most are in product codes DZH (Saw, Bone, Ac-Powered) and DZA (Drill, Dental, 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for American Safety Equipment Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Safety Equipment 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?

  • DZHSaw, Bone, Ac-Powered2decisions
  • DZADrill, Dental, Intraoral1decision
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • KPASlide Stainer, Automated1decision
  • DZJDriver, Wire, And Bone Drill, Manual1decision
  • EMMChisel, Osteotome, Surgical1decision

What has FDA decided for it lately?

  • K801010Kirschner WireAmerican Safety Equipment Corp. · 1980
  • K771699Cara-Stain Model 3000American Safety Equipment Corp. · 1977
  • K760956Surgical Micro DrillAmerican Safety Equipment Corp. · 1976
  • K760960Surgical Wire DriverAmerican Safety Equipment Corp. · 1976
  • K760958Surgical Oscillating SawAmerican Safety Equipment Corp. · 1976
  • K760957Surgical Reciprocating SawAmerican Safety Equipment Corp. · 1976
  • K760959Surgical ChiselAmerican Safety Equipment Corp. · 1976

All 7 as American Safety Equipment Corp. →