510(k) Report

FDA applicant

Neodental Chemical Products Co., Ltd.

Bethesda, MD5 decisions1996–20110 recalls

FDA records 5 decisions for Neodental Chemical Products Co., Ltd. (Bethesda, MD) from 1996 to 2011: 5 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EMA (Cement, Dental). Its devices cite 2 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 Neodental Chemical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neodental Chemical Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KIFResin, Root Canal Filling2decisions
  • EMACement, Dental1decision
  • EJKLiner, Cavity, Calcium Hydroxide1decision
  • EBGCrown And Bridge, Temporary, Resin1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K973667Vitapex Pre-Loaded Dental SyringeNeodental Chemical Products Co., Ltd. · 19974cite it
  • K111666Evadyne Temporary Crown and Bridge ResinNeodental Chemical Products Co., Ltd. · 20111cites it

What has FDA decided for it lately?

  • K111666Evadyne Temporary Crown and Bridge ResinNeodental Chemical Products Co., Ltd. · 2011
  • K111668Cavios Cavity LinerNeodental Chemical Products Co., Ltd. · 2011
  • K973667Vitapex Pre-Loaded Dental SyringeNeodental Chemical Products Co., Ltd. · 1997
  • K971642Dentalis Kez Endodonitc SealerNeodental Chemical Products Co., Ltd. · 1997
  • K955703Neo Dental Endodontic Irrigation SyringeNeodental Chemical Products Co., Ltd. · 1996

All 5 as Neodental Chemical Products Co., Ltd. →