510(k) Report

FDA applicant

Cruxell Corp.

Daejeon, KR2 decisions2019–20210 recalls

FDA records 2 decisions for Cruxell Corp. (Daejeon, KR) from 2019 to 2021: 2 510(k) clearances. All are in product code MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 3 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 Cruxell Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019: 12021: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Cruxell Corp. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cruxell Corp.’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

Which product codes does it file in?

  • MUHSystem, X-Ray, Extraoral Source, Digital2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 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.

  • K183637Cruxcan (CRX-1000)Cruxell Corp. · 20191cites it

What has FDA decided for it lately?

  • K211317CruxviewCruxell Corp. · 2021
  • K183637Cruxcan (CRX-1000)Cruxell Corp. · 2019

All 2 as Cruxell Corp. →