510(k) Report

FDA applicant

Pro-Dentec

Chicago, IL2 decisions1988–19960 recalls

FDA records 2 decisions for Pro-Dentec (Chicago, IL) from 1988 to 1996: 2 510(k) clearances. Most are in product codes EIX (Probe, Periodontic) and JEQ (Toothbrush, Powered). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Pro-Dentec’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pro-Dentec since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pro-Dentec by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pro-Dentec’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EIXProbe, Periodontic1decision
  • JEQToothbrush, Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K960245Vip Victor Interactive ProbePro-Dentec · 1996
  • K880589Rota-Dent Tooth CleanerPro-Dentec · 1988

All 2 as Pro-Dentec →