← Back to catalogue
Dental Zirconia Block
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 16187Model Multilayer ML-BL2-UT 89×71×16
Identity
- Trade Name
- Dental Zirconia Block EUDAMEDYUCERA FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- Multilayer ML-BL2-UT 89×71×16 EUDAMED16187 EUDAMEDML-BL2-UT FDA UDI
Identifiers
- Catalog Number
- UT 89×71×16mm FDA UDI
- Primary DI / UDI-DI
- 06942053534528 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06942053534528 EUDAMED
- 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 EUDAMEDN 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
MR Safe FDA UDI
Dental Zirconia Block by Shenzhen Yurucheng Dental Materials Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06942053534528 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 2d5115a7-8968-4973-9b9f-61ad2b392bcb 61 fields · synced Jul 10, 2026
- FDA UDI 2b82b6c1-5fe7-41fb-8897-94b9b2268146 36 fields · synced May 30, 2026