510(k) Report

FDA applicant

Maruchi

Wonju-Si, KR8 decisions2012–20230 recalls

FDA records 8 decisions for Maruchi (Wonju-Si, KR) from 2012 to 2023: 8 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EJK (Liner, Cavity, Calcium Hydroxide). Since 2016 its 510(k)s took a median of 325 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 5 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 Maruchi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012: 12014: 22018: 12021: 32023: 1
2012high 3 (2021) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Maruchi by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KIFResin, Root Canal Filling7decisions
  • EJKLiner, Cavity, Calcium Hydroxide1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 325 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K170175Endoseal MtaMaruchi · 20185cite it
  • K201799CleaniCalMaruchi · 20212cite it
  • K133054EndosealMaruchi · 20141cites it
  • K112078Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 20121cites it
  • K202015White ENDOSEAL MTAMaruchi · 20211cites it

What has FDA decided for it lately?

  • K213757Endocem MTA Premixed RegularMaruchi · 2023
  • K212229White Endoseal MTAMaruchi · 2021
  • K202015White ENDOSEAL MTAMaruchi · 2021
  • K201799CleaniCalMaruchi · 2021
  • K170175Endoseal MtaMaruchi · 2018
  • K133054EndosealMaruchi · 2014
  • K133042Endocem ZRMaruchi · 2014
  • K112078Endocem Mta (Mineral Trioxide Aggregate)Maruchi · 2012

All 8 as Maruchi →