FDA applicant

Tokuyama America, Inc.

Washington, DC22 decisions1990–20020 recalls

FDA records 22 decisions for Tokuyama America, Inc. (Washington, DC) from 1990 to 2002: 22 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 11 predicates, 4 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 Tokuyama America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tokuyama America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tokuyama 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 “Tokuyama”

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

Tokuyama Dental Corporation 19

Tokuyama 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 “Tokuyama”