510(k) Report

FDA applicant

Pertec of Wisconsin, Inc.

Suring, WI1 decision1998–19980 recalls

FDA records 1 decision for Pertec of Wisconsin, Inc. (Suring, WI) in 1998: 1 510(k) clearance. All are in product code LFC (Device, Caries Detection). 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 Pertec of Wisconsin, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pertec of Wisconsin, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pertec of Wisconsin, 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?

  • LFCDevice, Caries Detection1decision

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.

  • K982105Oral Potential Meter (Opm)Pertec of Wisconsin, Inc. · 19981cites it

What has FDA decided for it lately?

  • K982105Oral Potential Meter (Opm)Pertec of Wisconsin, Inc. · 1998

The one decision as Pertec of Wisconsin, Inc. →