Cleared Traditional

Esthetic Colorant

K220369 · Kuraray Noritake Dental, Inc. · Dental
Sep 2022
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K220369 is an FDA 510(k) clearance for the Esthetic Colorant, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on September 23, 2022, 227 days after receiving the submission on February 8, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K220369 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2022
Decision Date September 23, 2022
Days to Decision 227 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

Similar Devices — EIH Powder, Porcelain

All 477
IPS e.max Zirconia
K253953 · Ivoclar Vivadent, Inc. · Mar 2026
BruxZir? Shaded 16 PLUS
K254283 · Prismatik Dentalcraft, Inc. · Jan 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · Liaoning Upcera Co., Ltd. · Jan 2026
Glass Ceramic
K252789 · Shenzhen Xiangtong Co., Ltd. · Dec 2025
BruxZir? NOW
K252446 · Prismatik Dentalcraft, Inc. · Sep 2025
DenMat Multilayered Zirconia Disc
K251593 · Denmat Holding, LLC · Aug 2025