cameo™

FDA UDI

Class II (US FDA UDI)

by Shining 3D Tech Co., Ltd.

Identity

Trade Name: cameo™ FDA UDI
Generic Name: Intraoral optical scanning system FDA UDI
Device Name: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing. FDA UDI
Model / Reference: Elegant 3 FDA UDI
Description: The intraoral scanner uses an optical scanning method to directly collect 3D geometric data of the teeth and gums to be repaired in the patient's mouth, and provides 3D digital models for CAD/CAM denture design and processing. FDA UDI

Identifiers

Primary DI / UDI-DI: 06970163081779 FDA UDI
FDA Product Code: NOF FDA UDI
GMDN Term: Intraoral optical scanning system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3661 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

Yes

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

Moist Heat or Steam Sterilization FDA UDI

Category: Intraoral optical scanning system

cameo™ by Shining 3D Tech 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: Shining 3D Tech Co., Ltd.

Sources (1)

FDA UDI 6f167905-485e-4df7-b177-2c47ff5651f8 33 fields · synced Jun 8, 2026