510(k) Report

FDA applicant

Huge Dental Material Co., Ltd.

Dover, DE2 decisions2010–20200 recalls

FDA records 2 decisions for Huge Dental Material Co., Ltd. (Dover, DE) from 2010 to 2020: 2 510(k) clearances. Most are in product codes ELM (Denture, Plastic, Teeth) and EBG (Crown And Bridge, Temporary, Resin). Its devices cite 4 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 Huge Dental Material Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010: 12020: 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 — Huge Dental Material 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?

  • ELMDenture, Plastic, Teeth1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd. · 20101cites it
  • K201683PMMA BlockHuge Dental Material Co., Ltd. · 20201cites it

What has FDA decided for it lately?

  • K201683PMMA BlockHuge Dental Material Co., Ltd. · 2020
  • K101029Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethHuge Dental Material Co., Ltd. · 2010

All 2 as Huge Dental Material Co., Ltd. →