FDA applicant

Kuraray Medical, Inc.

New York, NY42 decisions2001–20120 recalls

FDA records 42 decisions for Kuraray Medical, Inc. (New York, NY) from 2001 to 2012: 42 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 81 predicates, 39 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, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007high 2 (2007) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kuraray Medical, Inc.’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 Co. 35 Kuraray Noritake Dental, Inc. 32 Kuraray America, Inc. 11 Kuraray Medical Kurashiki Plant 2 Kuraray Intl. Corp. 1

Kuraray Medical, Inc.

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”