Cleared Traditional

K241602 - Kingcera Dental Zirconia Blank (FDA 510(k) Clearance)

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

K241602 · Hunan Qinghao Puzhong Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
87d
Days
Class 2
Risk

K241602 is an FDA 510(k) clearance for the Kingcera Dental Zirconia Blank. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hunan Qinghao Puzhong Technology Co., Ltd. (Zhuzhou, CN). The FDA issued a Cleared decision on August 30, 2024 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hunan Qinghao Puzhong Technology Co., Ltd. devices

Submission Details

510(k) Number K241602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2024
Decision Date August 30, 2024
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
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 478
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K241602.
Eternal Art Porcelain Powders
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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
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K252446 · Prismatik Dentalcraft, Inc. · Sep 2025