510(k) Report

FDA applicant

A&E Bioceramic Co., Ltd.

Taoyuan County, TW1 decision2010–20100 recalls

FDA records 1 decision for A&E Bioceramic Co., Ltd. (Taoyuan County, TW) in 2010: 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 A&E Bioceramic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — A&E Bioceramic Co., Ltd. by year, 2010–2026Sources: 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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100145A&E Zirconia Blanks Model EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06A&E Bioceramic Co., Ltd. · 20101cites it

What has FDA decided for it lately?

  • K100145A&E Zirconia Blanks Model EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06A&E Bioceramic Co., Ltd. · 2010

The one decision as A&E Bioceramic Co., Ltd. →