Cleared Traditional

K220369 - Esthetic Colorant

K220369 is the FDA 510(k) clearance for Esthetic Colorant by Kuraray Noritake Dental, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K220369 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
227d
Days
Class 2
Risk

K220369 is an FDA 510(k) clearance for the Esthetic Colorant. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on September 23, 2022 after a review of 227 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Kuraray Noritake Dental, Inc. devices

Submission Details

510(k) Number K220369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 127d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K220369.
Dental Zirconia Ceramic
K222626 · Aidite (Qinhuangdao) Technology Co., Ltd. · Dec 2022
Zirconia Block
K222520 · Yilink (Tianjin) Biotechnology Co., Ltd. · Nov 2022
Perfit FS Dental Zirconia Fully Sintered Block
K222686 · Vatech Acucera, Inc. · Oct 2022
BruxZir NOW
K220816 · Prismatik Dentalcraft, Inc. · Aug 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242 · Hunan Vsmile Biotechnology Co., Ltd. · Jul 2022
KDF Zirconia Disc
K221429 · Denken-Highdental Co., Ltd. · Jul 2022