510(k) Report

FDA applicant

Tp Laboratories, Inc.

Mchenry, IL1 decision1978–19780 recalls

FDA records 1 decision for Tp Laboratories, Inc. (Mchenry, IL) in 1978: 1 510(k) clearance. All are in product code KMY (Positioner, Tooth, Preformed). 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 Tp Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tp Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • KMYPositioner, Tooth, Preformed1decision

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.

  • K780619Preformed Tooth PositionerTp Laboratories, Inc. · 19781cites it

What has FDA decided for it lately?

  • K780619Preformed Tooth PositionerTp Laboratories, Inc. · 1978

The one decision as Tp Laboratories, Inc. →