510(k) Report

FDA applicant

DiaDent Group International

Cheongju-Si, KR24 decisions2013–20260 recalls

FDA records 24 decisions for DiaDent Group International (Cheongju-Si, KR) from 2013 to 2026: 24 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 179 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 6 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 DiaDent Group International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013: 12019: 22020: 102021: 22022: 22023: 12026 (partial year): 6
2013high 10 (2020) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — DiaDent Group International by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like DiaDent Group International’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?

  • KIFResin, Root Canal Filling6decisions
  • EBFMaterial, Tooth Shade, Resin5decisions
  • KLEAgent, Tooth Bonding, Resin4decisions
  • ELWMaterial, Impression3decisions
  • EBGCrown And Bridge, Temporary, Resin2decisions
  • EMACement, Dental2decisions

Also: EBZ (2).

How long do its 510(k) reviews take?

Since 2016, its 22 510(k)s took a median of 179 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 194 days; 10 of its 22 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 6 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.

  • K200809D-LUX+DiaDent Group International · 20204cite it
  • K192510DIAFIL & DIAFIL CapsuleDiaDent Group International · 20202cite it
  • K213401DIAPLUS UniversalDiaDent Group International · 20221cites it
  • K182625Diapex PlusDiaDent Group International · 20191cites it
  • K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro KitDiaDent Group International · 20201cites it
  • K231552Dia-CemDiaDent Group International · 20231cites it

What has FDA decided for it lately?

  • K254152Dia-X Sil Light BodyDiaDent Group International · 2026
  • K254142Dia-X Sil Heavy BodyDiaDent Group International · 2026
  • K261166Dia-CemDiaDent Group International · 2026
  • K261093DiafilDiaDent Group International · 2026
  • K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International · 2026
  • K254112Dia-X Sil BiteDiaDent Group International · 2026
  • K231552Dia-CemDiaDent Group International · 2023
  • K220804Dia-X Bond UniversalDiaDent Group International · 2022

All 24 as DiaDent Group International →