Orchestrate 3D Orthodontic Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181112 FDA 510(k)
- FDA Product Code
- PNN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Orchestrate 3D Orthodontic Software is a digital tool classified as orthodontic software, designed to assist in the planning, simulation, and treatment of orthodontic cases. It integrates with dental imaging to provide three-dimensional visualization and analysis of dental structures, aiding clinicians in creating customized treatment plans for alignment and occlusion adjustments.
The software is supplied as a standalone digital application for use in dental offices, clinics, or orthodontic practices. It operates on compatible hardware platforms and does not require sterilization or physical handling, making it a reusable, non-invasive tool. The device is regulated under FDA 510(k) clearance (K181112) as a Class II medical device under regulation number 872.5470, with no MRI safety considerations specified. No single-use or sterility requirements are indicated.
Frequently asked questions
What is the primary purpose of the Orchestrate 3D Orthodontic Software and how does it integrate with dental treatment planning?
The Orchestrate 3D Orthodontic Software is designed to assist clinicians in planning, simulating, and executing orthodontic treatments by providing three-dimensional visualization and analysis of dental structures. It integrates with dental imaging to help create customized treatment plans for aligning teeth and adjusting occlusion, streamlining the workflow for orthodontic adjustments without requiring physical handling or sterilization.
Is the Orchestrate 3D Orthodontic Software reusable or single-use, and what are the implications for its use in a clinical setting?
The Orchestrate 3D Orthodontic Software is a reusable digital tool, as it operates on compatible hardware platforms without physical sterilization or handling requirements. This makes it ideal for repeated use in dental offices, clinics, or orthodontic practices, ensuring consistent performance across multiple cases without the need for disposal or reprocessing.
What regulatory pathway was followed for the FDA clearance of the Orchestrate 3D Orthodontic Software, and what classification does it hold?
The Orchestrate 3D Orthodontic Software was cleared through the FDA’s 510(k) process under the traditional review pathway, classified as a Class II medical device under regulation number 872.5470. The clearance (K181112) confirms it is substantially equivalent to a predicate device, ensuring it meets established safety and effectiveness standards for orthodontic software.
Does the Orchestrate 3D Orthodontic Software require any special storage conditions or considerations?
Since the Orchestrate 3D Orthodontic Software is a digital application, it does not require physical storage like traditional medical devices. However, it must be installed on compatible hardware platforms and maintained with regular software updates to ensure optimal performance and compliance with manufacturer guidelines. No sterility or environmental storage conditions are specified.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181112 | Class II | Active |
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Manufacturer
- Manufacturer
- Orchestrate 3D
Sources (1)
- FDA 510(k) K181112 24 fields · synced Sep 19, 2026