Cleared Traditional

K131534 - KATANA ZIRCONIA (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131534 · Kuraray Noritake Dental, Inc. · Dental device
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Oct 2013
Decision
135d
Days
Class 2
Risk

K131534 is an FDA 510(k) clearance for the KATANA ZIRCONIA. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Kuraray Noritake Dental, Inc. (Washington, US). The FDA issued a Cleared decision on October 11, 2013 after a review of 135 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 K131534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2013
Decision Date October 11, 2013
Days to Decision 135 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 127d · This submission: 135d
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.

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