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Sign in to claim this brandOrchestrate 3D
US
Last updated May 31, 2026
What Orchestrate 3D makes
Orchestrate 3D specializes in chairside dental milling systems that integrate CAD/CAM technology for same-visit restorative procedures. Their devices are designed to produce dental restorations, such as crowns and bridges, directly in the clinical setting using precise milling techniques.
The company’s portfolio is regulated under Class II devices in the US, with products authorised through FDA pathways including 510(k) clearances and the Unique Device Identification (UDI) system. These devices are listed under the relevant FDA registries for medical devices.
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 Orchestrate 3D manufacture?
Orchestrate 3D specializes in chairside dental milling systems that incorporate CAD/CAM technology. These devices enable dentists to create dental restorations, such as crowns and bridges, in a single visit by milling precise restorations directly in the clinical setting. The focus is on streamlining same-visit restorative procedures for improved patient care.
Where is Orchestrate 3D based?
Orchestrate 3D is based in the United States. The company’s headquarters and operations are located within the country, aligning its regulatory compliance and device authorisation processes with US standards.
Which regulatory registries list Orchestrate 3D’s devices?
Orchestrate 3D’s devices are listed under the FDA’s 510(k) clearance pathway and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance with US medical device regulations, allowing for tracking and monitoring of authorised products.
How are Orchestrate 3D’s devices classified under US regulations?
Orchestrate 3D’s devices fall under Class II classification in the US. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as dental milling systems used for chairside restorations.
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
- 054153356
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orchestrate 3D | 1 | FDA UDI | Class II | Active |
| Orchestrate 3D | K181112 | FDA 510(k) | Class II | Active |
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