FDA applicant
Kuraray Noritake Dental, Inc.
FDA records 32 decisions for Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP) from 2012 to 2025: 32 510(k) clearances. Most are in product codes EIH (Powder, Porcelain) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 182 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 11 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
How often FDA has decided Kuraray Noritake Dental, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Kuraray Noritake Dental, 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) ReportOther applicant names beginning “Kuraray”
FDA records each applicant name separately; these may or may not be the same firm.