510(k) Report

FDA applicant

Sewonmedix, Inc.

Sa-Sang-Gu, KR2 decisions2016–20230 recalls

FDA records 2 decisions for Sewonmedix, Inc. (Sa-Sang-Gu, KR) from 2016 to 2023: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 5 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 Sewonmedix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Sewonmedix, Inc. by year, 2016–2026Sources: 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 5 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.

  • K153521IH Implant SystemSewonmedix, Inc. · 20162cite it
  • K222707IH Implant SystemSewonmedix, Inc. · 20231cites it

What has FDA decided for it lately?

  • K222707IH Implant SystemSewonmedix, Inc. · 2023
  • K153521IH Implant SystemSewonmedix, Inc. · 2016

All 2 as Sewonmedix, Inc. →