Identity
- Trade Name
- SHINING 3D® Intraoral Scanner 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
- Aoralscan 2 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
- 06970163080017 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraoral optical scanning system
SHINING 3D® Intraoral Scanner 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 d82feeeb-9e6b-459a-b147-b3f19b808078 33 fields · synced Jun 8, 2026