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Arena

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref FM-ZDS9818-B4

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-ZDS9818-B4 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08800055703954 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

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Cleared under the same submission

K190112 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ARUM DENTISTRY Co., Ltd.

Sources (2)

  • FDA UDI 9964b66b-5afe-427d-9aec-f3d902a3a6db 33 fields · synced Oct 7, 2026
  • EUDAMED 83e39c7b-b680-443b-83ef-ba9ca5afec67 61 fields · synced Jul 8, 2026