Cleared Traditional

K201608 - GenesisZr UHT700 Zirconia

K201608 is an FDA 510(k) clearance for GenesisZr UHT700 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 227-day FDA review.

K201608 · United Dental Resources Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
227d
Days
Class 2
Risk

K201608 is an FDA 510(k) clearance for the GenesisZr UHT700 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 28, 2021 after a review of 227 days - an extended review 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: 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 - K201608

510(k) Number K201608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2020
Decision Date January 28, 2021
Days to Decision 227 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
100d slower than avg
Panel avg: 127d · This submission: 227d
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 K201608.
Non-Sterile Zirconia Block
K201492 · Bioden Co., Ltd. · Mar 2021
Perfit ZR HT Dental Zirconia blank
K203351 · Vatech Acucera, Inc. · Mar 2021
GenesisZr 4Y+ (ST1100) Zirconia
K201915 · United Dental Resources Corporation · Feb 2021
Dentsply Sirona Universal Spray Glazes
K202629 · Dentsply Sirona · Jan 2021
X-cera Pre-shaded Zirconia Blanks
K202673 · Dongguan Xiangtong Co., Ltd. · Dec 2020
HCG Zirconia Ceramic Block
K193090 · Hocheng Corporation · Oct 2020