510(k) Report

FDA applicant

Bloomden Bioceramics (HuNan) Co., Ltd.

Changsha, CN2 decisions2021–20260 recalls

FDA records 2 decisions for Bloomden Bioceramics (HuNan) Co., Ltd. (Changsha, CN) from 2021 to 2026: 2 510(k) clearances. All are in product code EIH (Powder, Porcelain). Its devices cite 2 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 Bloomden Bioceramics (HuNan) Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 12026 (partial year): 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 — Bloomden Bioceramics (HuNan) Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EIHPowder, Porcelain2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K212765Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K260370Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026
  • K212765Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021

All 2 as Bloomden Bioceramics (HuNan) Co., Ltd. →