FDA applicant

Kuraray Intl. Corp.

New York, NY1 decision1994–19940 recalls

FDA records 1 decision for Kuraray Intl. Corp. (New York, NY) in 1994: 1 510(k) clearance. All are in product code KLE (Agent, Tooth Bonding, Resin). 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 Intl. Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kuraray Intl. Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kuraray Intl. Corp.’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 Co. 35 Kuraray Noritake Dental, Inc. 32 Kuraray America, Inc. 11 Kuraray Medical Kurashiki Plant 2

Kuraray Intl. Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Kuraray”