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DMAX Coloring Liquid - DMAX Coloring Liquid

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173769

by DMAX Co., Ltd.

Identifiers

510(k) Number
K173769 FDA 510(k)
FDA Product Code
EIH FDA 510(k)
Models / Variants
DMAX Coloring Liquid FDA 510(k)
Chang's Liquid FDA 510(k)
Confident Coloring Liquid FDA 510(k)
CAMeleon Coloring Liquid FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6660 FDA 510(k)
Regulation Number
872.6660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DMAX Coloring Liquid is a dental accessory liquid designed to provide individual tooth shading for zirconium dioxide restorative materials. It is applied to zirconia restorations to adjust the shade before sintering, enabling clinicians to achieve the desired tooth color.

The product is distributed by DMAX Co., Ltd. and has received FDA 510(k) clearance (product code EIH, K173769) as a substantially equivalent dental device. It is supplied as a liquid intended for use with zirconia components; specific sterility, single‑use or reuse details are not provided in the available data.

Frequently asked questions

What is the DMAX Coloring Liquid used for?

The DMAX Coloring Liquid is a dental accessory liquid designed to provide individual tooth shading for zirconium dioxide restorative materials. It is applied to zirconia restorations to adjust the shade before sintering, enabling clinicians to achieve the desired tooth color.

How is the DMAX Coloring Liquid supplied?

The DMAX Coloring Liquid is supplied as a liquid intended for use with zirconia components. Specific details about sterility, single-use or reuse are not provided in the available data.

What regulatory approvals does the DMAX Coloring Liquid have?

The DMAX Coloring Liquid has received FDA 510(k) clearance (product code EIH, K173769) as a substantially equivalent dental device. It is distributed by DMAX Co., Ltd.

What are the alternative names for the DMAX Coloring Liquid?

The DMAX Coloring Liquid is also known as Chang's Liquid, Confident Coloring Liquid, and CAMeleon Coloring Liquid. These are alternative names for the same product manufactured by DMAX Co., Ltd.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid ..., Dmax Coloring Liquid; Chang's Liquid; Confident Coloring Liquid ..., Color Liquid Classic - DMAX, Zirconia Coloring Liquids | Dmax Dental America Corp, Home | Dmax Dental America Corp

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
DMAX Co., Ltd.

Sources (1)

  • FDA 510(k) K173769 24 fields · synced Oct 6, 2026