Cleared Traditional

K193090 - HCG Zirconia Ceramic Block

K193090 is an FDA 510(k) clearance for HCG Zirconia Ceramic Block, manufactured by Hocheng Corporation. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K193090 · Hocheng Corporation · Dental device
Download Printable Device Report (PDF)
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Oct 2020
Decision
358d
Days
Class 2
Risk

K193090 is an FDA 510(k) clearance for the HCG Zirconia Ceramic Block. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hocheng Corporation (Taipei City, TW). The FDA issued a Cleared decision on October 29, 2020 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hocheng Corporation devices

FDA 510(k) Submission Details - K193090

510(k) Number K193090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2019
Decision Date October 29, 2020
Days to Decision 358 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
231d slower than avg
Panel avg: 127d · This submission: 358d
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 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K193090.
GenesisZr UHT700 Zirconia
K201608 · United Dental Resources Corporation · Jan 2021
Dentsply Sirona Universal Spray Glazes
K202629 · Dentsply Sirona · Jan 2021
X-cera Pre-shaded Zirconia Blanks
K202673 · Dongguan Xiangtong Co., Ltd. · Dec 2020
Coloring Liquid
K192723 · Aidite (Qinhuangdao) Technology Co., Ltd. · Aug 2020
VITA LUMEX AC
K193434 · Vita Zahnfabrik GmbH H Rauter & CO · Jul 2020
Dental Glass Ceramics Blocks
K192231 · Aidite (Qinhuangdao) Technology Co., Ltd. · Jul 2020