Yucera

FDA UDI

Class N (US FDA UDI)

by Shenzhen Yurucheng Dental Materials Co., Ltd.

Identity

Trade Name: YUCERA FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Model / Reference: ML-C1-3D FDA UDI

Identifiers

Catalog Number: 3DPlus 89×71×14mm FDA UDI
Primary DI / UDI-DI: 06942053526011 FDA UDI
510(k) Number: K214003 FDA UDI
K214005 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K214003 also covers:

K214005 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 4b775376-1167-4050-9042-0649fe1165ce 36 fields · synced Jun 8, 2026