510(k) Report

FDA applicant

Shandong Huge Dental Material Corporation

Rizhao City, CN9 decisions2016–20260 recalls

FDA records 9 decisions for Shandong Huge Dental Material Corporation (Rizhao City, CN) from 2016 to 2026: 9 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 10 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 Shandong Huge Dental Material Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2016: 12017: 12019: 12020: 12022: 22025: 12026 (partial year): 2
2016high 2 (2022) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Shandong Huge Dental Material Corporation by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing3decisions
  • EMACement, Dental2decisions
  • EIHPowder, Porcelain1decision
  • MQCMouthguard, Prescription1decision
  • NXCAligner, Sequential1decision
  • ELWMaterial, Impression1decision

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 100 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 154 days; 4 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K213994Flexible BlockShandong Huge Dental Material Corporation · 20221cites it

What has FDA decided for it lately?

  • K260376Denture BaseShandong Huge Dental Material Corporation · 2026
  • K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026
  • K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation · 2025
  • K220680Denture Base PolymersShandong Huge Dental Material Corporation · 2022
  • K213994Flexible BlockShandong Huge Dental Material Corporation · 2022
  • K201684A-Silicone for Bite RegistrationShandong Huge Dental Material Corporation · 2020
  • K181747Orthodontic ApplianceShandong Huge Dental Material Corporation · 2019
  • K160345Glass Ionomer CementShandong Huge Dental Material Corporation · 2017

All 9 as Shandong Huge Dental Material Corporation →