510(k) Report

FDA applicant

Bdc Dental Corporation, Ltd.

Guangzhou, CN2 decisions2021–20250 recalls

FDA records 2 decisions for Bdc Dental Corporation, Ltd. (Guangzhou, CN) from 2021 to 2025: 2 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and FXX (Mask, Surgical). Its devices cite 2 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 Bdc Dental Corporation, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12025: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Bdc Dental Corporation, Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bdc Dental Corporation, 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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