Shining 3d®

FDA UDI

Class II (US FDA UDI)

by Hangzhou SHINING3D Dental Technology Co., Ltd.

Identity

Trade Name: SHINING 3D® FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: The product is used for 3D printing denture teeth. FDA UDI
Model / Reference: CB11-A3 FDA UDI
Description: The product is used for 3D printing denture teeth. FDA UDI

Identifiers

Primary DI / UDI-DI: 06975338700226 FDA UDI
FDA Product Code: PZY FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3590 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Category: Dental appliance fabrication material, resin

Shining 3d® by Hangzhou SHINING3D Dental Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Hangzhou SHINING3D Dental Technology Co., Ltd.

Sources (1)

FDA UDI 569b70a7-dd73-402d-aa3e-e1a8fdb3b503 33 fields · synced May 30, 2026