510(k) Report

FDA applicant

American Custom Medical, Inc.

Lubbock, TX5 decisions1994–19971 recall

FDA records 5 decisions for American Custom Medical, Inc. (Lubbock, TX) from 1994 to 1997: 5 510(k) clearances. Most are in product codes NPK (Barrier, Synthetic, Intraoral) and EMX (Balloon, Epistaxis). 1 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 American Custom Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Custom Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Custom Medical, 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?

  • NPKBarrier, Synthetic, Intraoral3decisions
  • EMXBalloon, Epistaxis1decision
  • FTLMesh, Surgical, Polymeric1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K935137Tefgen-FDAmerican Custom Medical, Inc. · 19942cite it
  • K965205Tefgen - LSAmerican Custom Medical, Inc. · 19971cites it

What has FDA decided for it lately?

  • K965205Tefgen - LSAmerican Custom Medical, Inc. · 1997
  • K964656Tefgen Guided Tissue MembraneAmerican Custom Medical, Inc. · 1997
  • K944413Acm Ptfe Surgical MeshAmerican Custom Medical, Inc. · 1994
  • K935137Tefgen-FDAmerican Custom Medical, Inc. · 19941 recall
  • K933800Fluorofilm (R)American Custom Medical, Inc. · 1994

All 5 as American Custom Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K935137TefGen is an implant material which is intended to be used as a temporary space-making…Jun 3, 2004