510(k) Report

FDA applicant

Driskell Bioengineering

Galena, OH4 decisions1985–19880 recalls

FDA records 4 decisions for Driskell Bioengineering (Galena, OH) from 1985 to 1988: 4 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Driskell Bioengineering’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Driskell Bioengineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Driskell Bioengineering 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-Form4decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K853788DB Precision Implant SystemDriskell Bioengineering · 19852cite it

What has FDA decided for it lately?

  • K875243DB Precision Implant System, 2000 Series W/HacDriskell Bioengineering · 1988
  • K875242DB Precision Implant System, 1000 Series W/HacDriskell Bioengineering · 1988
  • K860982DB Precision Implant System, 2000 SeriesDriskell Bioengineering · 1986
  • K853788DB Precision Implant SystemDriskell Bioengineering · 1985

All 4 as Driskell Bioengineering →