FDA applicant

Tokuyama Dental Corporation

Tokyo, JP19 decisions2003–20210 recalls

FDA records 19 decisions for Tokuyama Dental Corporation (Tokyo, JP) from 2003 to 2021: 19 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 14 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 Dental Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2007high 3 (2017) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Tokuyama Dental Corporation’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 “Tokuyama”

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

Tokuyama America, Inc. 22

Tokuyama Dental Corporation

Which product codes does it file in?

How long do its 510(k) reviews take?

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”