Cleared Traditional

K190436 - KATANA Zirconia Block

K190436 is the FDA 510(k) clearance for KATANA Zirconia Block by Kuraray Noritake Dental, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K190436 · Kuraray Noritake Dental, Inc. · Dental device
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May 2019
Decision
90d
Days
Class 2
Risk

K190436 is an FDA 510(k) clearance for the KATANA Zirconia Block. 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 May 23, 2019 after a review of 90 days - within the typical 510(k) review window.

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 K190436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2019
Decision Date May 23, 2019
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K190436.
Razor, Everest, U&C Liquid
K191902 · U&C International Co., Ltd. · Oct 2019
Vintage Art Universal
K191794 · Shofu Dental Corporation · Oct 2019
Shaders ZR
K190569 · Digital Age Dental Lab · Jul 2019
Dental Ceramic
K182350 · Baot Biological Technology Co., Ltd. · May 2019
ArgenZ HT+
K190079 · The Argen Corporation · Apr 2019
Prettau, ICE, Z-White zirconia blanks
K183304 · Zirkonzahn Srl · Apr 2019