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Arena

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref FM-ZD9820-B4Ref FM-ZD9824-A1Ref FM-ZD9810Ref FM-ZDS9818-B4Ref FM-ZDS9822-A1Ref FM-D20-A3Ref FM-D24-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-ZD9810 EUDAMEDFDA UDI
FM-D24-A2 EUDAMEDFDA UDI
FM-ZDS9818-B4 EUDAMEDFDA UDI
FM-ZDS9822-A1 EUDAMEDFDA UDI
FM-ZD9824-A1 EUDAMEDFDA UDI
FM-D20-A3 EUDAMEDFDA UDI
FM-ZD9820-B4 EUDAMEDFDA UDI
FM-Z22 FDA UDI

Identifiers

Primary DI / UDI-DI
08800055701110 EUDAMEDFDA UDI
08800055704784 EUDAMEDFDA UDI
08800055703954 EUDAMEDFDA UDI
08800055701653 EUDAMEDFDA UDI
08800055701479 EUDAMEDFDA UDI
08800055704869 EUDAMEDFDA UDI
08800055703770 EUDAMEDFDA UDI
08800055705064 FDA 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

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.

Cleared under the same submission

K190112 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

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 (15)

  • FDA UDI 13f982ec-16a9-4bcf-92f9-fd2c271ea5af 33 fields · synced Sep 30, 2026
  • FDA UDI c56b7331-ad7e-47ee-b6df-0540e10dc2c4 32 fields · synced May 29, 2026
  • FDA UDI b8dec004-79ff-412a-9f62-f7f52a7d50e5 33 fields · synced May 30, 2026
  • FDA UDI 9964b66b-5afe-427d-9aec-f3d902a3a6db 33 fields · synced May 30, 2026
  • FDA UDI 7bd8ba1a-94d4-4f6b-bed3-e28e341d4fb0 33 fields · synced May 30, 2026
  • FDA UDI 847a11d8-049d-4179-a9a7-4ee0d4066a2a 33 fields · synced May 30, 2026
  • FDA UDI 692d9349-8305-4f79-bcae-2f01fddf5ff8 33 fields · synced May 30, 2026
  • FDA UDI b9498c90-416c-4c62-911e-114381b27ad0 33 fields · synced May 30, 2026
  • EUDAMED 52b162c3-194e-4fb0-ac97-419d53984ab6 61 fields · synced Jul 8, 2026
  • EUDAMED 979423db-7624-4b72-86c5-3bee3bb7ad6f 61 fields · synced Jul 8, 2026
  • EUDAMED e0f1ac1c-4d59-4651-a5eb-0b37703f37a8 61 fields · synced Jul 8, 2026
  • EUDAMED 83e39c7b-b680-443b-83ef-ba9ca5afec67 61 fields · synced Jul 8, 2026
  • EUDAMED eee9c386-bc8b-4c02-b5f3-574e90a46a24 61 fields · synced Aug 1, 2026
  • EUDAMED 8df1491c-564c-4582-97da-63fe4e68d36e 61 fields · synced Aug 1, 2026
  • EUDAMED f4632a08-a293-475c-812a-9d3149ffc26a 61 fields · synced Aug 1, 2026