Arena

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref FM-ZD9826-A2

by ARUM DENTISTRY Co., Ltd.

Identity

Trade Name: Arena EUDAMEDFDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: Non-Sterile Zirconia Block EUDAMED
Model / Reference: FM-ZD9826-A2 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 08800055701783 EUDAMEDFDA UDI
Basic UDI-DI: 88000557ZIR2B EUDAMED
510(k) Number: K190112 FDA UDI
FDA Product Code: EIH FDA UDI
EMDN Code: Q01020604 ORTHODONTIC DENTAL PROSTHESES EUDAMED
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

Arena by ARUM DENTISTRY Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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
Multi M Series — DMAX Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
CGI — CERAGROUP INDUSTRIES · Class II
Dental Zirconia Ceramics — Liaoning Upcera Co., Ltd. · Class IIa

Cleared under the same submission

K190112 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ARUM DENTISTRY Co., Ltd.

Sources (2)

FDA UDI fd4b20a0-c8c9-48ac-aac7-0952ad9150d7 33 fields · synced Oct 8, 2026
EUDAMED e6ab7aa7-4cc7-4c69-9b50-395d6b25f857 61 fields · synced Oct 7, 2026