FDA applicant

Bio Concept Co., Ltd.

Changzhou, CN3 decisions2015–20220 recalls

FDA records 3 decisions for Bio Concept Co., Ltd. (Changzhou, CN) from 2015 to 2022: 3 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 3 predicates, 1 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 Bio Concept Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Bio Concept Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bio Concept 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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Bio Concept Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?