510(k) Report

FDA applicant

Thm Biomedical, Inc.

Duluth, MN1 decision1996–19960 recalls

FDA records 1 decision for Thm Biomedical, Inc. (Duluth, MN) in 1996: 1 510(k) clearance. All are in product code LYC (Bone Grafting Material, Synthetic). 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 Thm Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Thm Biomedical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Thm Biomedical, 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?

  • LYCBone Grafting Material, Synthetic1decision

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.

  • K940643Osmed Epi-GuideThm Biomedical, Inc. · 19961cites it

What has FDA decided for it lately?

  • K940643Osmed Epi-GuideThm Biomedical, Inc. · 1996

The one decision as Thm Biomedical, Inc. →