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Yucera

FDA UDIEUDAMED

Class N (US FDA UDI)

Ref 16187Model Multilayer ML-A2-4D 98×12

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-A2-4D 98×12 EUDAMED
16187 EUDAMED
ML-A2-4D FDA UDI

Identifiers

Catalog Number
4D 98×12mm FDA UDI
Primary DI / UDI-DI
06942053541076 EUDAMEDFDA UDI
Basic UDI-DI
B-06942053541076 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

Yucera by Shenzhen Yurucheng Dental Materials Co., Ltd. — Class N — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K214003 also covers:

K214005 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Shenzhen Yurucheng Dental Materials Co., Ltd.

Sources (2)

  • FDA UDI cbdeb2c7-36f9-4dce-8509-e23a394737d7 36 fields · synced Oct 6, 2026
  • EUDAMED 7c2fe78b-fd00-4cac-affa-427088289e6f 61 fields · synced Oct 6, 2026