Cleared Traditional

HCG Zirconia Ceramic Block (K193090) - FDA 510(k) Clearance

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

K193090 · Hocheng Corporation · Dental device
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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

Submission Details

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.

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 479
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K193090.
DCMhotbond zircon
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Eternal Art Porcelain Powders
K260067 · Shandong Huge Dental Material Corporation · Apr 2026
IPS e.max Zirconia
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BruxZir® Shaded 16 PLUS
K254283 · Prismatik Dentalcraft, Inc. · Jan 2026
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
K253973 · Liaoning Upcera Co., Ltd. · Jan 2026
Glass Ceramic
K252789 · Shenzhen Xiangtong Co., Ltd. · Dec 2025