510(k) Report

FDA applicant

Surgident

Seongnam-Si, KR2 decisions2018–20190 recalls

FDA records 2 decisions for Surgident (Seongnam-Si, KR) from 2018 to 2019: 2 510(k) clearances. Most are in product codes JEY (Plate, Bone) 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.

FDA’s records also spell it “Surgident Co., Ltd.”.

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 Surgident’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Surgident by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JEYPlate, Bone1decision
  • 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 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.

  • K170697GBR systemSurgident · 20182cite it

What has FDA decided for it lately?

  • K173570SD AbutmentSurgident Co., Ltd. · 2019
  • K170697GBR systemSurgident · 2018

The one decision as Surgident →The one decision as Surgident Co., Ltd. →