Cleared Traditional

K182642 - GenesisZr 4Y Zirconia

K182642 is an FDA 510(k) clearance for GenesisZr 4Y Zirconia, manufactured by United Dental Resources Corporation. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K182642 · United Dental Resources Corporation · Dental device
Download Printable Device Report (PDF)
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Jan 2019
Decision
123d
Days
Class 2
Risk

K182642 is an FDA 510(k) clearance for the GenesisZr™ 4Y Zirconia. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by United Dental Resources Corporation (University Park, US). The FDA issued a Cleared decision on January 25, 2019 after a review of 123 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 United Dental Resources Corporation devices

FDA 510(k) Submission Details - K182642

510(k) Number K182642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date January 25, 2019
Days to Decision 123 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
4d faster than avg
Panel avg: 127d · This submission: 123d
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 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K182642.
Jensen Shade Effect Liquids
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ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
K182833 · The Argen Corporation · Feb 2019
VINTAGE PRO
K181496 · Shofu Dental Corporation · Dec 2018
Erran Dental Zirconia
K182068 · Hangzhou Erran Technology Co., Ltd. · Dec 2018
Ceramic Denture Zirconia Ceramics Block
K181816 · Qinhuangdao Silide Ceramic Technology Co., Ltd. · Nov 2018