FDA applicant

Dexcowin Co., Ltd.

Seoul, KR5 decisions2009–20170 recalls

FDA records 5 decisions for Dexcowin Co., Ltd. (Seoul, KR) from 2009 to 2017: 5 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and IZL (System, X-Ray, Mobile). Its devices cite 4 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 Dexcowin Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009high 2 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Dexcowin Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dexcowin Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Dexcowin”

FDA records each applicant name separately; these may or may not be the same firm.

Dexcowin Global, Inc. 1

Dexcowin Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Dexcowin”