510(k) Report

FDA applicant

Ruthibras Imp. Exp. Com. DE Materiais Odontologico

Littleton, CO1 decision2002–20020 recalls

FDA records 1 decision for Ruthibras Imp. Exp. Com. DE Materiais Odontologico (Littleton, CO) in 2002: 1 510(k) clearance. All are in product code ELM (Denture, Plastic, Teeth). 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 Ruthibras Imp. Exp. Com. DE Materiais Odontologico’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ruthibras Imp. Exp. Com. DE Materiais Odontologico since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ruthibras Imp. Exp. Com. DE Materiais Odontologico 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?

  • ELMDenture, Plastic, Teeth1decision

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.

  • K022299Trilux, Z-Tone, Acry RockRuthibras Imp. Exp. Com. DE Materiais Odontologico · 20021cites it

What has FDA decided for it lately?

  • K022299Trilux, Z-Tone, Acry RockRuthibras Imp. Exp. Com. DE Materiais Odontologico · 2002

The one decision as Ruthibras Imp. Exp. Com. DE Materiais Odontologico →