510(k) Report

FDA applicant

Dental Components, Inc.

Newberg, OR2 decisions1997–20040 recalls

FDA records 2 decisions for Dental Components, Inc. (Newberg, OR) from 1997 to 2004: 2 510(k) clearances. All are in product code EIA (Unit, Operative Dental). 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 Dental Components, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dental Components, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dental Components, 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?

  • EIAUnit, Operative Dental2decisions

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.

  • K971727Dci Water PurifierDental Components, Inc. · 19971cites it

What has FDA decided for it lately?

  • K033925BiofreeDental Components, Inc. · 2004
  • K971727Dci Water PurifierDental Components, Inc. · 1997

All 2 as Dental Components, Inc. →