FDA applicant

Kuraray America, Inc.

New York, NY11 decisions1997–20110 recalls

FDA records 11 decisions for Kuraray America, Inc. (New York, NY) from 1997 to 2011: 11 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and KLE (Agent, Tooth Bonding, Resin). Its devices cite 53 predicates, 2 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 America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kuraray America, Inc.’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 Medical Kurashiki Plant 2 Kuraray Intl. Corp. 1

Kuraray America, 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”