Cleared Traditional

K131117 - ZIRMON SERIES

K131117 is an FDA 510(k) clearance for ZIRMON SERIES, manufactured by Kuwotech Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K131117 · Kuwotech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Jul 2013
Decision
95d
Days
Class 2
Risk

K131117 is an FDA 510(k) clearance for the ZIRMON SERIES. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Kuwotech Co., Ltd. (Anaheim, US). The FDA issued a Cleared decision on July 26, 2013 after a review of 95 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 Kuwotech Co., Ltd. devices

FDA 510(k) Submission Details - K131117

510(k) Number K131117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2013
Decision Date July 26, 2013
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
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 298
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K131117.
ZIRTOUGH
K133211 · Kuraray Noritake Dental, Inc. · Mar 2014
KATANA ZIRCONIA
K131534 · Kuraray Noritake Dental, Inc. · Oct 2013
UNIVERSAL PASTE STAINS AND GLAZE
K130604 · Prismatik Dentalcraft, Inc. · Sep 2013
ZENOLUX
K130184 · Wieland Dental + Technik GmbH & Co. KG · May 2013
VINTAGE MP PRESS OVER
K122614 · Shofu Dental Corporation · May 2013
BRUXZIR SHADED
K130924 · Prismatik Dentalcraft, Inc. · May 2013