Manufacturer registered with FDA

DMAX Co., Ltd.

Daegu, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10033605Contract manufacturerManufacturer1 clearance in five years

Device types listed: 1
Brands and models: 19
510(k) clearances: 22018–2025
Markets registered in: 33 registrations outside the US
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name DMAX Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: South KoreaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	DMAX Co., Ltd.	2 clearances	2018–2025	Below
Brazil	ANVISA	Manufacturer	DMAX CO., LTD	2	2023–2023	Pure Global AI
Taiwan	TFDA	Manufacturer	DMAX Co., Ltd.	1	2023–2023	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What DMAX Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Maker	ADD-ZAlpha+CAMeleon Coloring LiquidChang's LiquidConfident Coloring LiquidDMAX Coloring LiquidMaxZirMulti M SeriesNatura MNatura S 9 more NaturaZ HTNaturaZ IllusionNaturaZ Series(B16, B20, B42, B60, B98, B100)Zmaxx M DarkZmaxx M LiteZmaxx M PureZmaxx S LiteZmaxx S PureZmaxx T Series	2010

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names DMAX Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
12 Jun 2025	K250826	Multi M Series	EIH Porcelain Powder
8 Mar 2018	K173769	DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid	EIH Porcelain Powder

Also lists devices cleared under other names

DMAX Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Dental Solutions, LLC (1).

Decided	510(k)	Device	Applicant	Device type
18 Jun 2009	K091096	NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100	Dental Solutions, LLC	EIH Porcelain Powder

Registered establishments

Establishment	Location	What it does
DMAX Co., Ltd.FDA reg. 3008564629	Daegu, South Korea	Contract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10033605). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.