510(k) Report

FDA applicant

Leader Italia S.R.L.

New York, NY2 decisions2007–20120 recalls

FDA records 2 decisions for Leader Italia S.R.L. (New York, NY) from 2007 to 2012: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Leader Italia S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leader Italia S.R.L. 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?

  • DZEImplant, Endosseous, Root-Form2decisions

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.

  • K062931Implus Implant SystemLeader Italia S.R.L. · 20073cite it

What has FDA decided for it lately?

  • K120792Tixos Implant SystemLeader Italia S.R.L. · 2012
  • K062931Implus Implant SystemLeader Italia S.R.L. · 2007

All 2 as Leader Italia S.R.L. →