Dental Zirconia Blank & Coloring Liquid— 510(k) K261046

Name: FDA 510(k) clearance K261046
Creator: U.S. Food and Drug Administration
Published: 2026-07-17

Substantially Equivalent

Hunan Qinghao Puzhong Technology Co., Ltd.

FDA 510(k) clearance K261046 for Dental Zirconia Blank & Coloring Liquid, Substantially Equivalent on 2026-07-17. Applicant: Hunan Qinghao Puzhong Technology Co., Ltd.. Device class: 2.

Summary

Hunan Qinghao Puzhong Technology's Dental Zirconia Blank & Coloring Liquid is filed under EIH, porcelain powder. The name refers to zirconia, which the code name doesn't mention, and the record gives no composition.

Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).

The applicant filed from Zhuzhou, China. Review took 108 calendar days (March 31 to July 17, 2026).

Clearance details

Applicant: Hunan Qinghao Puzhong Technology Co., Ltd.
Product code: Product code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2026-03-31
Decision date: 2026-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.