Cleared Traditional

K250673 - CERABIEN MiLai

K250673 is the FDA 510(k) clearance for CERABIEN MiLai by Kuraray Noritake Dental, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K250673 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
84d
Days
Class 2
Risk

K250673 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. (Tokyo, JP). The FDA issued a Cleared decision on May 29, 2025 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kuraray Noritake Dental, Inc. devices

Submission Details

510(k) Number K250673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2025
Decision Date May 29, 2025
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 K250673.
ARENA Star, Galaxy Star
K250063 · Arum Dentistry Co., Ltd. · Jul 2025
Multi M Series
K250826 · Dmax Co., Ltd. · Jun 2025
zirkon
K251084 · Estetic Ceram AG · Jun 2025
Biomic Color Opaque
K250534 · Aidite (Qinhuangdao) Technology Co., Ltd. · May 2025
ZircaGlow & ZircaGlow HT Zirconia
K250393 · United Zirconia · May 2025
Dental Zirconia Ceramic
K250811 · Aidite (Qinhuangdao) Technology Co., Ltd. · Apr 2025