Multi M Series

FDA UDI

Class II (US FDA UDI)

by DMAX Co., Ltd.

Identity

Trade Name: Multi M Series FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Model / Reference: OMC2Z10 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800155234976 FDA UDI
510(k) Number: K250826 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

The Multi M Series is a dental material made of ceramic materials, specifically zirconium oxide, designed for manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. It is intended to create implantable and removable restorations using this material. The device does not contain MRI safety information, has been subject to several premarket submissions, and was released in 2025. This material cannot be reused for fabrication, making it a single-use item.

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Razor / MegaPlus — U&C International Co., Ltd · Class II
rainbow High shine — Genoss · Class II
Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
CGI — CERAGROUP INDUSTRIES · Class II
ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Dental Zirconia Ceramics — Liaoning Upcera Co., Ltd. · Class IIa
Henry Schein — HENRY SCHEIN, INC. · Class II

Cleared under the same submission

K250826 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: DMAX Co., Ltd.

Sources (1)

FDA UDI 40f658af-0b1d-48b1-99bc-0473e7ad6ed5 33 fields · synced Jul 24, 2026