510(k) Report

FDA applicant

Yilink (Tianjin) Biotechnology Co., Ltd.

Tianjin, CN3 decisions2022–20240 recalls

FDA records 3 decisions for Yilink (Tianjin) Biotechnology Co., Ltd. (Tianjin, CN) from 2022 to 2024: 3 510(k) clearances. All are in product code EIH (Powder, Porcelain). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Yilink (Tianjin) Biotechnology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 12023: 12024: 1
2022high 1 (2022) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Yilink (Tianjin) Biotechnology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIHPowder, Porcelain3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 87 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K242400Dental porcelain powderYilink (Tianjin) Biotechnology Co., Ltd. · 2024
  • K222513Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd. · 2023
  • K222520Zirconia BlockYilink (Tianjin) Biotechnology Co., Ltd. · 2022

All 3 as Yilink (Tianjin) Biotechnology Co., Ltd. →