510(k) Report

FDA applicant

Lascod Spa

Sesto Fiorentino, IT2 decisions2012–20200 recalls

FDA records 2 decisions for Lascod Spa (Sesto Fiorentino, IT) from 2012 to 2020: 2 510(k) clearances. All are in product code ELW (Material, Impression). Its devices cite 1 predicate, 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 Lascod Spa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12020: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Lascod Spa by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ELWMaterial, Impression2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K121824Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2Lascod Spa · 20121cites it

What has FDA decided for it lately?

  • K201184Lascod Impression MaterialsLascod Spa · 2020
  • K121824Alginor Alginelle Type 1 and 2 Millenium Kromopan 1 and 2Lascod Spa · 2012

All 2 as Lascod Spa →