510(k) Report

FDA applicant

Aci, Inc.

Lakewood, CO2 decisions2006–20070 recalls

FDA records 2 decisions for Aci, Inc. (Lakewood, CO) from 2006 to 2007: 2 510(k) clearances. Most are in product codes GXD (Generator, Lesion, Radiofrequency) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, neurology panel, where it files most

How often FDA has decided Aci, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aci, 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?

  • GXDGenerator, Lesion, Radiofrequency1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K063753GFX Nerve Ablation SystemAci, Inc. · 20071cites it

What has FDA decided for it lately?

  • K063753GFX Nerve Ablation SystemAci, Inc. · 2007
  • K061501Flexo Dental Resin MaterialAci, Inc. · 2006

All 2 as Aci, Inc. →