510(k) Report

FDA applicant

We Dong Myung Dental Industrial Co., Ltd.

Marietta, GA4 decisions2003–20030 recalls

FDA records 4 decisions for We Dong Myung Dental Industrial Co., Ltd. (Marietta, GA) in 2003: 4 510(k) clearances. Most are in product codes EJT (Alloy, Gold-Based Noble Metal) and EJJ (Alloy, Amalgam). Its devices cite 4 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 We Dong Myung Dental Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for We Dong Myung Dental Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — We Dong Myung Dental Industrial Co., Ltd. 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?

  • EJTAlloy, Gold-Based Noble Metal3decisions
  • EJJAlloy, Amalgam1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82We Dong Myung Dental Industrial Co., Ltd. · 2003
  • K033435E-Sarang 86, DM78, DM55We Dong Myung Dental Industrial Co., Ltd. · 2003
  • K033434BestaloyWe Dong Myung Dental Industrial Co., Ltd. · 2003
  • K030206APEX 90We Dong Myung Dental Industrial Co., Ltd. · 2003

All 4 as We Dong Myung Dental Industrial Co., Ltd. →