FDA applicant

Hygedent, Inc.

Beijing, CN4 decisions2014–20210 recalls

FDA records 4 decisions for Hygedent, Inc. (Beijing, CN) from 2014 to 2021: 4 510(k) clearances. All are in product code ELW (Material, Impression). Its devices cite 4 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 Hygedent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Hygedent, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hygedent, Inc.’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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Hygedent, Inc.

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?