Cleared Traditional

K261046 - Dental Zirconia Blank & Coloring Liquid

K261046 is the FDA 510(k) clearance for Dental Zirconia Blank & Coloring Liquid by Hunan Qinghao Puzhong Technology Co., Ltd.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K261046 · Hunan Qinghao Puzhong Technology Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2026
Decision
108d
Days
Class 2
Risk

K261046 is an FDA 510(k) clearance for the Dental Zirconia Blank & Coloring Liquid. 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 July 17, 2026 after a review of 108 days - within the typical 510(k) review window.

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 Hunan Qinghao Puzhong Technology Co., Ltd. devices

Submission Details

510(k) Number K261046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2026
Decision Date July 17, 2026
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
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 261
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K261046.
Obsidian® Press Over Zirconia
K262239 · Prismatik Dentalcraft, Inc. · Jul 2026
DCMhotbond zircon
K253191 · Dental Creativ Management GmbH · May 2026
Eternal Art Porcelain Powders
K260067 · Shandong Huge Dental Material Corporation · Apr 2026
IPS e.max Zirconia
K253953 · Ivoclar Vivadent, Inc. · Mar 2026
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