Cleared Traditional

GenesisZr UHT700 Zirconia (K201608) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 184
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