Identity
- Trade Name
- Dental System FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion. FDA UDI
- Model / Reference
- 2018-1 FDA UDI
- Description
- Dental System is an intuitive 3D CAD software for creating accurate, customized dental restorations and therapeutic models covering treatments to rebuild and protect the tooth surface and the occlusion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05902729752473 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3661 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
Dental System by 3shape A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- 3shape A/S
Sources (1)
- FDA UDI c72e0de6-416b-4eea-b6cf-fc7befe20580 35 fields · synced Jun 1, 2026