510(k) Report

FDA applicant

Sgs International, Ltd.

Budapest, HU2 decisions2014–20190 recalls

FDA records 2 decisions for Sgs International, Ltd. (Budapest, HU) from 2014 to 2019: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 10 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 Sgs International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Sgs International, Ltd. by year, 2014–2026Sources: 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 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K182219SGS Dental Implants SystemSgs International, Ltd. · 20191cites it
  • K133362SGS Dental ImplantSgs International, Ltd. · 20141cites it

What has FDA decided for it lately?

  • K182219SGS Dental Implants SystemSgs International, Ltd. · 2019
  • K133362SGS Dental ImplantSgs International, Ltd. · 2014

All 2 as Sgs International, Ltd. →