Planmeca ProMax 3D Max
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Planmeca Oy
Identifiers
- 510(k) Number
- K160506 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Planmeca ProMax 3D Max is a Cone Beam Computed Tomography (CBCT) X-ray unit designed for maxillofacial imaging. It provides high-resolution volumetric imaging of the skull and surrounding anatomical structures, enabling detailed visualization of bone and soft tissue for diagnostic purposes.
This device is intended for use in dental and maxillofacial radiology settings and is supplied as a reusable, non-sterile medical instrument. It operates under FDA 510(k) clearance, MDD, and MDR regulations, with a maximum field of view (FOV) capable of capturing whole skull images. Storage and handling follow standard medical imaging protocols, and its regulatory status includes classification as a Class II device.
Frequently asked questions
What types of medical settings is the Planmeca ProMax 3D Max intended for, and what anatomical areas does it primarily image?
The Planmeca ProMax 3D Max is designed specifically for dental and maxillofacial radiology settings. It provides high-resolution volumetric imaging of the skull and surrounding anatomical structures, including bone and soft tissue, enabling detailed visualization for diagnostic purposes in these specialized fields.
Is the Planmeca ProMax 3D Max a single-use or reusable device, and what are the sterility requirements?
The Planmeca ProMax 3D Max is a reusable medical instrument and is supplied in a non-sterile state. Since it is not a disposable device, it must be cleaned, disinfected, and maintained according to standard medical imaging protocols to ensure safe and effective reuse.
What is the maximum field of view (FOV) capability of the Planmeca ProMax 3D Max, and how does this benefit clinical use?
The Planmeca ProMax 3D Max is capable of capturing whole skull images, meaning its maximum field of view (FOV) allows for comprehensive volumetric imaging of the entire craniofacial region. This capability is particularly useful for evaluating complex anatomical structures and planning treatments that require full-scope visualization.
How is the regulatory status of the Planmeca ProMax 3D Max determined, and what classification does it hold?
The Planmeca ProMax 3D Max is classified as a Class II medical device under FDA regulations and is authorized through FDA 510(k) clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). Its classification reflects the level of risk and oversight required for devices used in diagnostic imaging, particularly those involving radiation exposure.
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. Sources consulted: PDF Planmeca ProMax 3D Max - res.cloudinary.com, Planmeca ProMax 3D Plus - See beyond the dentition, Planmeca ProMax 3D LE - The gateway to the Planmeca ProMax® 3D family
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160506 | Class II | Active |
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Manufacturer
- Manufacturer
- Planmeca Oy
Sources (2)
- FDA 510(k) K160506 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026