510(k) Report

FDA applicant

Germiphene Corp.

Brantford, Ont, CA5 decisions1989–19980 recalls

FDA records 5 decisions for Germiphene Corp. (Brantford, Ont, CA) from 1989 to 1998: 5 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and EJR (Agent, Polishing, Abrasive, Oral Cavity). 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 Germiphene Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Germiphene Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Germiphene 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?

  • EIAUnit, Operative Dental2decisions
  • EJRAgent, Polishing, Abrasive, Oral Cavity2decisions
  • MEDSterilant, Medical Devices1decision

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.

  • K964796Odyssey I Dental Water UnitGermiphene Corp. · 19971cites it

What has FDA decided for it lately?

  • K983847Modification of: Odyssey I Dental Water UnitGermiphene Corp. · 1998
  • K961289VapopheneGermiphene Corp. · 1997
  • K964796Odyssey I Dental Water UnitGermiphene Corp. · 1997
  • K942851Smile Integrated Prophylaxis Paste RingsGermiphene Corp. · 1994
  • K894933PerlidentGermiphene Corp. · 1989

All 5 as Germiphene Corp. →