MEDIUMRegulatoryTier 1
FDA 510(k) K261046: Dental Zirconia Blank & Coloring Liquid
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
A new zirconia blank and coloring liquid cleared via the 510(k) pathway gives general and prosthetic dentists another supply option for CAD/CAM restorations, but because it is a 'substantially equivalent' Class II device, it does not introduce new clinical standards or immediate reimbursement changes.
Key points
- Manufacturer: Hunan Qinghao Puzhong Technology Co., Ltd.; clearance date and predicate device not specified in the record.
- Product codes EIH / Regulation 872.6660 cover porcelain powders and pre-sintered zirconia blanks used for crowns, bridges, and implant abutments.
- Traditional 510(k) clearance signals the product is considered equivalent to existing zirconia systems already on the U.S. market—no new training or equipment investment required.
- Practice impact: labs and in-office mills can add this line to diversify vendor risk or negotiate pricing, but owners should still validate flexural strength and shade-match data before high-volume adoption.
Who should care
OwnerDSOSpecialist
Read the original on openFDA Dental Devices
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