meddevicedb.com FDA Device Reference

Dental Zirconia Blank & Coloring Liquid

K261046 Class II Traditional
Decision Date
2026-07-17
Sponsor / Applicant
Hunan Qinghao Puzhong Technology Co., Ltd.

Technical Specification

510(k) Submission ID K261046
Product Code EIH
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6660
Decision Date 2026-07-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Dental Zirconia Blank & Coloring Liquid received FDA 510(k) clearance under submission number K261046, sponsored by Hunan Qinghao Puzhong Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-07-17.

Classification & Regulation

This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.