510(k) Report

FDA applicant

Warantec Co., Ltd.

Seongnam-Si, KR4 decisions2009–20230 recalls

FDA records 4 decisions for Warantec Co., Ltd. (Seongnam-Si, KR) from 2009 to 2023: 4 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 320 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 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 Warantec Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2009: 12018: 12023: 2
2009high 2 (2023) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Warantec Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Warantec Co., Ltd.’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?

  • NHAAbutment, Implant, Dental, Endosseous2decisions
  • DZEImplant, Endosseous, Root-Form2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 320 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K081748Oneplant Dental Implant SystemWarantec Co., Ltd. · 20094cite it
  • K172345IU Implant SystemWarantec Co., Ltd. · 20182cite it

What has FDA decided for it lately?

  • K221972Warantec Custom AbutmentWarantec Co., Ltd. · 2023
  • K221969IU Implant System AbutmentWarantec Co., Ltd. · 2023
  • K172345IU Implant SystemWarantec Co., Ltd. · 2018
  • K081748Oneplant Dental Implant SystemWarantec Co., Ltd. · 2009

All 4 as Warantec Co., Ltd. →