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Sign in to claim this brandWhat IMAGOWORKS Inc. makes
IMAGOWORKS Inc. manufactures chairside CAD/CAM dental milling systems designed for same-visit crown fabrication. Their portfolio includes the Dentbird Crown, a device tailored for dental laboratories and practices to create dental restorations directly in the clinic using digital design and milling technology.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. IMAGOWORKS Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does IMAGOWORKS Inc. manufacture?
IMAGOWORKS Inc. specializes in chairside CAD/CAM dental milling systems, specifically designed for fabricating dental crowns in a single visit. Their primary focus is on devices that enable dental practices to create restorations directly in the clinic using digital design and milling technology, such as the Dentbird Crown.
Where is IMAGOWORKS Inc. based?
IMAGOWORKS Inc. is headquartered in the United States. This location is relevant for understanding the company’s regulatory framework and compliance context, particularly for devices marketed in the US.
How are IMAGOWORKS Inc.’s devices classified under FDA regulations?
IMAGOWORKS Inc.’s devices, such as the Dentbird Crown, are classified as Class II under FDA regulations. This classification is determined based on the level of risk associated with the device, where Class II devices require special controls to ensure safety and effectiveness beyond general controls.
Are IMAGOWORKS Inc.’s devices listed in any regulatory registries?
Yes, IMAGOWORKS Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 963215271
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dentbird Crown | V.3.X.X | FDA UDI | Class II | Active |
| Dentbird Crown | V.4.X.X | FDA UDI | Class II | Active |
| Dentbird Solution | Dentbird Crown V.2.x.x | FDA UDI | Class II | Unknown |
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