FDA applicant

Shinhung Mst Co., Ltd.

Wonju-Si, KR7 decisions2013–20230 recalls

FDA records 7 decisions for Shinhung Mst Co., Ltd. (Wonju-Si, KR) from 2013 to 2023: 7 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 236 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 4 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 Shinhung Mst Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2013high 3 (2023) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Shinhung Mst Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Shinhung”

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

Shinhung Company, Ltd. 2

Shinhung Mst Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Shinhung”