Cleared Traditional

K261046 - Dental Zirconia Blank & Coloring Liquid

K261046 is an FDA 510(k) clearance for Dental Zirconia Blank & Coloring Liquid, manufactured by Hunan Qinghao Puzhong Technology Co., Ltd.. The device is a Class 2 Dental device with 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
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K261046

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Beijing Xinranyicheng Medicine & Technology Co., Ltd.
Yuqing Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIH Powder, Porcelain

All 400
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K261046.
Any-Zircos
K262074 · Mediclus Co., Ltd. · Aug 2026
Obsidian® Press Over Zirconia
K262239 · Prismatik Dentalcraft, Inc. · Jul 2026
Rosetta SM, Rosetta SP
K260859 · Hass Corp. · Jun 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