510(k) Report

FDA applicant

Dfl Industria E Comercio SA

Aventura, FL2 decisions2013–20130 recalls

FDA records 2 decisions for Dfl Industria E Comercio SA (Aventura, FL) in 2013: 2 510(k) clearances. All are in product code EMA (Cement, Dental). Its devices cite 5 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, dental panel, where it files most

How often FDA has decided Dfl Industria E Comercio SA’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2013: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Dfl Industria E Comercio SA by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EMACement, Dental2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K123824Vitro Fil LCDfl Industria E Comercio SA · 2013
  • K123826Vitro MolarDfl Industria E Comercio SA · 2013

All 2 as Dfl Industria E Comercio SA →