510(k) Report

FDA applicant

Medical Products Laboratories, Inc.

Philadelphia, PA2 decisions1985–20040 recalls

FDA records 2 decisions for Medical Products Laboratories, Inc. (Philadelphia, PA) from 1985 to 2004: 2 510(k) clearances. Most are in product codes LBH (Varnish, Cavity) and EFT (Cleanser, Denture, Over The Counter). 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 Medical Products Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Products Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Products 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?

  • LBHVarnish, Cavity1decision
  • EFTCleanser, Denture, Over The Counter1decision

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.

  • K040098VarnishamericaMedical Products Laboratories, Inc. · 20042cite it

What has FDA decided for it lately?

  • K040098VarnishamericaMedical Products Laboratories, Inc. · 2004
  • K844572Pre-Klene Enamel CleanerMedical Products Laboratories, Inc. · 1985

All 2 as Medical Products Laboratories, Inc. →