Identity
- Trade Name
- 3Shape Scan Bodies FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, laboratory FDA UDI
- Device Name
- Demo kit box only FDA UDI
- Model / Reference
- NRDbox FDA UDI
- Description
- Demo kit box only FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05902729752381 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, laboratory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
A comprehensive medical device directory, specifically the 3Shape Scan Bodies dental milling system. The device is designed for automated computer-aided design and computer-aided manufacturing of custom-made dental restorations and/or orthodontic appliances.
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
- 3shape Trios A/S
Sources (1)
- FDA UDI c3600b2d-8d7a-4372-b23e-7ff945348ac8 35 fields · synced Jul 23, 2026