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Dental Zirconia Block

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 16187Model Color D3-UT 95×14

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
Color D3-UT 95×14 EUDAMED
16187 EUDAMED
D3 FDA UDI

Identifiers

Catalog Number
UT 95×14mm FDA UDI
Primary DI / UDI-DI
06942053509939 EUDAMEDFDA UDI
Basic UDI-DI
B-06942053509939 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 dental zirconia ceramic block manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd. This device is designed for use in dentistry, providing a durable and biocompatible material for various applications. It features a sleek color design, making it an attractive addition to any dental laboratory or clinic.

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
Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133

Sources (2)

  • EUDAMED 64b1dfca-e8c5-469c-8137-49f94dc13ff9 61 fields · synced Jul 29, 2026
  • FDA UDI 6d83265a-918d-402f-84ef-ce00aa6b9b18 36 fields · synced May 30, 2026