510(k) Report

FDA applicant

Dms Co., Ltd.

Wonju-Si, KR2 decisions1993–20190 recalls

FDA records 2 decisions for Dms Co., Ltd. (Wonju-Si, KR) from 1993 to 2019: 2 510(k) clearances. Most are in product codes EKX (Handpiece, Direct Drive, Ac-Powered) and FPP (Stretcher, Hand-Carried). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Dms”.

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 Dms Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dms Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dms 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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Which product codes does it file in?

  • EKXHandpiece, Direct Drive, Ac-Powered1decision
  • FPPStretcher, Hand-Carried1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K180953AnyCheck IMT-100Dms Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K180953AnyCheck IMT-100Dms Co., Ltd. · 2019
  • K924275Restraining StretcherDms · 1993

The one decision as Dms Co., Ltd. →The one decision as Dms →