510(k) Report

FDA applicant

Dentkist, Inc.

Gunpo-Si, KR2 decisions2016–20200 recalls

FDA records 2 decisions for Dentkist, Inc. (Gunpo-Si, KR) from 2016 to 2020: 2 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and ELW (Material, Impression). Its devices cite 2 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 Dentkist, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12020: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Dentkist, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin1decision
  • ELWMaterial, Impression1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K152766CharmFlexDentkist, Inc. · 20162cite it

What has FDA decided for it lately?

  • K193496CharmFilDentkist, Inc. · 2020
  • K152766CharmFlexDentkist, Inc. · 2016

All 2 as Dentkist, Inc. →