Identity
- Trade Name
- Dentbird Solution FDA UDI
- Generic Name
- Dental milling system, CAD/CAM, chairside FDA UDI
- Device Name
- Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj). FDA UDI
- Model / Reference
- Dentbird Crown V.2.x.x FDA UDI
- Description
- Dentbird Crown is a software intended to support dental crown design using 3D data from a patient's oral scan image. It receives oral scan data as input and recommends the tooth number, margin lines, and initial values for a dental crown design using a deep learning model and CAD algorithm. Additionally, users can directly design the dental crown. The software can accept and export 3D intraoral scan data in a universal file format (.stl, .ply, .obj). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809953520007 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
- 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
Dentbird Solution by IMAGOWORKS Inc. — 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
- IMAGOWORKS Inc.
Sources (1)
- FDA UDI 78993b31-963a-45ab-9b1e-76844ac1c2f1 34 fields · synced May 30, 2026