510(k) Report

FDA applicant

Bofors Nobelpharma, Inc.

Mchenry, IL3 decisions1982–19840 recalls

FDA records 3 decisions for Bofors Nobelpharma, Inc. (Mchenry, IL) from 1982 to 1984: 3 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…). 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 Bofors Nobelpharma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bofors Nobelpharma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bofors Nobelpharma, Inc. 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?

  • DZEImplant, Endosseous, Root-Form2decisions
  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K820013Titanium Implant DevicesBofors Nobelpharma, Inc. · 19824cite it
  • K841551Osseointegrated Fixtures-Tissue IntegrBofors Nobelpharma, Inc. · 19841cites it

What has FDA decided for it lately?

  • K841813Tissue Integrated Prosthesis DrillBofors Nobelpharma, Inc. · 1984
  • K841551Osseointegrated Fixtures-Tissue IntegrBofors Nobelpharma, Inc. · 1984
  • K820013Titanium Implant DevicesBofors Nobelpharma, Inc. · 1982

All 3 as Bofors Nobelpharma, Inc. →