Shining 3d®

FDA UDI

Class I (US FDA UDI)

by Shining 3D Tech Co., Ltd.

Identity

Trade Name: SHINING 3D® FDA UDI
Generic Name: Jaw physiology evaluation system FDA UDI
Device Name: The product uses optical scanning method to collect facial 3D data and jaw movement tracking data to provide 3D digital models for facial and oral CAD design. FDA UDI
Model / Reference: MetiSmile-MR FDA UDI
Description: The product uses optical scanning method to collect facial 3D data and jaw movement tracking data to provide 3D digital models for facial and oral CAD design. FDA UDI

Identifiers

Primary DI / UDI-DI: 06970163087672 FDA UDI
FDA Product Code: NFS FDA UDI
GMDN Term: Jaw physiology evaluation system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.2060 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

Category: Jaw physiology evaluation system

Shining 3d® by Shining 3D Tech Co., Ltd. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Shining 3D Tech Co., Ltd.

Sources (1)

FDA UDI 03fc49cc-61e3-42ab-81cd-e29bef441eaf 33 fields · synced May 29, 2026