510(k) Report

FDA applicant

Chengdu Besmile Biotechnology Co., Ltd.

Chengdu, CN1 decision2017–20170 recalls

FDA records 1 decision for Chengdu Besmile Biotechnology Co., Ltd. (Chengdu, CN) in 2017: 1 510(k) clearance. All are in product code EIH (Powder, Porcelain). 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 Chengdu Besmile Biotechnology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Chengdu Besmile Biotechnology Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIHPowder, Porcelain1decision

What has FDA decided for it lately?

  • K170894Zirconia Dental CeramicsChengdu Besmile Biotechnology Co., Ltd. · 2017

The one decision as Chengdu Besmile Biotechnology Co., Ltd. →