510(k) Report

FDA applicant

Oneday Biotech Co., Ltd.

Daegu, KR2 decisions2023–20240 recalls

FDA records 2 decisions for Oneday Biotech Co., Ltd. (Daegu, KR) from 2023 to 2024: 2 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). 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 Oneday Biotech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Oneday Biotech Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form1decision
  • NHAAbutment, Implant, Dental, Endosseous1decision

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.

  • K231753Oneday Implant AbutmentOneday Biotech Co., Ltd. · 20241cites it

What has FDA decided for it lately?

  • K231753Oneday Implant AbutmentOneday Biotech Co., Ltd. · 2024
  • K222946Oneday Mini Implant SystemOneday Biotech Co., Ltd. · 2023

All 2 as Oneday Biotech Co., Ltd. →