FDA applicant

Kuraray Medical Kurashiki Plant

New York, NY2 decisions2004–20050 recalls

FDA records 2 decisions for Kuraray Medical Kurashiki Plant (New York, NY) from 2004 to 2005: 2 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 12 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 Kuraray Medical Kurashiki Plant’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kuraray Medical Kurashiki Plant since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kuraray Medical Kurashiki Plant by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kuraray Medical Kurashiki Plant’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Kuraray”

FDA records each applicant name separately; these may or may not be the same firm.

Kuraray Medical, Inc. 42 Kuraray Co. 35 Kuraray Noritake Dental, Inc. 32 Kuraray America, Inc. 11 Kuraray Intl. Corp. 1

Kuraray Medical Kurashiki Plant

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kuraray”