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Dental Zirconia Block

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 16187Model Multilayer ML-A3.5-3DPlus 95×10

by Shenzhen Yurucheng Dental Materials Co., Ltd.

Identity

Trade Name
Dental Zirconia Block EUDAMED
YUCERA FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Zirconia Dental Ceramics EUDAMED
Model / Reference
Multilayer ML-A3.5-3DPlus 95×10 EUDAMED
16187 EUDAMED
ML-A3.5-3D FDA UDI

Identifiers

Catalog Number
3DPlus 95×10mm FDA UDI
Primary DI / UDI-DI
06942053524413 EUDAMEDFDA UDI
Basic UDI-DI
B-06942053524413 EUDAMED
510(k) Number
K214003 FDA UDI
K214005 FDA UDI
FDA Product Code
PKJ FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
N FDA UDI
Market of Registration
Türkiye EUDAMED
Commercial Distribution
Not 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

The Dental Zirconia Block is a high-quality, precision instrument used in dental procedures. Its advanced zirconia material ensures superior durability and resistance to corrosion, making it an ideal choice for dental professionals. With its compact design and user-friendly interface, the Zirconia Dental Ceramics device offers unparalleled performance and reliability.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Yurucheng Dental Materials Co., Ltd.
EUDAMED SRN
CN-MF-000011505
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (2)

  • EUDAMED 1d270310-e6e6-4ce4-90ff-839a1f0bf455 61 fields · synced Aug 1, 2026
  • FDA UDI 6ea9f5b8-c37f-4d6b-be57-08da26002311 36 fields · synced May 30, 2026