Identity
- Trade Name
- YUCERA FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- ML-B4-3D FDA UDI
Identifiers
- Catalog Number
- 3DPlus 89×71×18mm FDA UDI
- Primary DI / UDI-DI
- 06942053525786 FDA UDI
- FDA Product Code
- PKJ FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yucera by Shenzhen Yurucheng Dental Materials Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K214003 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yurucheng Dental Materials Co., Ltd.
Sources (1)
- FDA UDI af8d005f-dcc2-4481-af35-b7a6248be958 36 fields · synced May 31, 2026