510(k) Report

FDA applicant

Dio Corporation

Busan, KR14 decisions2010–20230 recalls

FDA records 14 decisions for Dio Corporation (Busan, KR) from 2010 to 2023: 14 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 217 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 4 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 Dio Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2010: 12011: 12013: 12017: 12018: 42019: 12020: 32021: 12023: 1
2010high 4 (2018) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Dio Corporation by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dio Corporation’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?

  • DZEImplant, Endosseous, Root-Form7decisions
  • NHAAbutment, Implant, Dental, Endosseous5decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 217 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 200 days; 4 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 4 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.

  • K122519Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation · 20135cite it
  • K181037DIO CAD/CAM AbutmentDio Corporation · 20185cite it
  • K161987UF (II) Narrow Implant System - Fixture, UF (II) Narrow Implant System - SuprastructureDio Corporation · 20173cite it
  • K170608UF (II) Implant SystemDio Corporation · 20182cite it
  • K192263UCLA CCM AbutmentDio Corporation · 20202cite it
  • K193623DIOnavi-DentureDio Corporation · 20201cites it

What has FDA decided for it lately?

  • K220253Eco Abutment, Multiunit AbutmentDio Corporation · 2023
  • K210828DIOnavi-Denture02Dio Corporation · 2021
  • K193623DIOnavi-DentureDio Corporation · 2020
  • K193404UF (II) Bar holder abutmentDio Corporation · 2020
  • K192263UCLA CCM AbutmentDio Corporation · 2020
  • K190048UF (II) Anatomic abutmentDio Corporation · 2019
  • K181037DIO CAD/CAM AbutmentDio Corporation · 2018
  • K182194UV Active Implant SystemDio Corporation · 2018

All 14 as Dio Corporation →