FDA applicant

Kuraray Co.

New York, NY35 decisions1985–20000 recalls

FDA records 35 decisions for Kuraray Co. (New York, NY) from 1985 to 2000: 35 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Kuraray Company, Ltd.”.

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 Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kuraray Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

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 Noritake Dental, Inc. 32 Kuraray America, Inc. 11 Kuraray Medical Kurashiki Plant 2 Kuraray Intl. Corp. 1

Kuraray Co.

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”