Identity
- Trade Name
- Circle One FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Circle ONE Design is a software device intended to support the design of the following dental prostheses: full crowns, partial crowns (onlay, inlay, overlay), veneers. It allows the import of 3D intraoral scan data and provides automated prosthetic design proposals that can be reviewed, adjusted and exported for manufacturing. FDA UDI
- Model / Reference
- V.1.X.X FDA UDI
- Description
- Circle ONE Design is a software device intended to support the design of the following dental prostheses: full crowns, partial crowns (onlay, inlay, overlay), veneers. It allows the import of 3D intraoral scan data and provides automated prosthetic design proposals that can be reviewed, adjusted and exported for manufacturing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760434300004 FDA UDI
- FDA Product Code
- NOF FDA UDI
- GMDN Term
- Dental milling system, CAD/CAM, chairside 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
No
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
Category: Dental milling system, CAD/CAM, chairside
Circle One by Circle Anatoscope Intuitive Design — 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
- Circle Anatoscope Intuitive Design
Sources (1)
- FDA UDI be384216-267d-413e-af20-273e139ebda6 33 fields · synced Jun 6, 2026