Cleared Traditional

K213147 - CERABIEN MiLai

K213147 is an FDA 510(k) clearance for CERABIEN MiLai, manufactured by Kuraray Noritake Dental, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K213147 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
182d
Days
Class 2
Risk

K213147 is an FDA 510(k) clearance for the CERABIEN MiLai. 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 March 28, 2022 after a review of 182 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

FDA 510(k) Submission Details - K213147

510(k) Number K213147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date March 28, 2022
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 127d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K213147.
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221051 · Changsha Honchon Technology Co., Ltd. · Jul 2022
Coloring Liquid
K220017 · Dongguan Xiangtong Co., Ltd. · Jun 2022
BruxZir Opaque Coloring Liquid
K220960 · Prismatik Dentalcraft, Inc. · Jun 2022
Vintage Prime Press
K212939 · Shofu Dental Corporation · Mar 2022
Dental Zirconia Pre-shaded Block
K214003 · Shenzhen Yurucheng Dental Materials Co., Ltd. · Feb 2022
Zirconia Dental Ceramics
K214005 · Shenzhen Yurucheng Dental Materials Co., Ltd. · Feb 2022