510(k) Report

FDA applicant

Tycom Dental

Irvine, CA2 decisions1996–19970 recalls

FDA records 2 decisions for Tycom Dental (Irvine, CA) from 1996 to 1997: 2 510(k) clearances. All are in product code EKS (File, Pulp Canal, Endodontic). Its devices cite 3 predicates, 1 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, dental panel, where it files most

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

FDA decisions per year

No FDA decision for Tycom Dental since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tycom Dental 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?

  • EKSFile, Pulp Canal, Endodontic2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K962031Quantec Series 2000 Endodontic FilesTycom Dental · 19963cite it

What has FDA decided for it lately?

  • K971319NT Series Endodontic Files, Mac Series Endodontic FilesTycom Dental · 1997
  • K962031Quantec Series 2000 Endodontic FilesTycom Dental · 1996

All 2 as Tycom Dental →