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Planmeca Promax 3D Max

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K093590

by Planmeca Oy

Identifiers

510(k) Number
K093590 FDA 510(k)
FDA Product Code
MUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Planmeca Promax 3D Max is a digital extraoral X-ray system designed for dental imaging. It captures high-resolution three-dimensional images of the maxillofacial region, enabling precise assessment of dental and skeletal structures for diagnostic and treatment planning purposes.

This device is intended for use in dental clinics and oral surgery settings. Supplied as a reusable system, it requires proper calibration and maintenance to ensure accurate imaging. The Promax 3D Max operates under FDA 510(k) clearance, EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR) compliance, with a classification as a Class II medical device. It is not single-use and must be stored in a clean, controlled environment to maintain performance and sterility standards.

Frequently asked questions

What types of clinical settings is the Planmeca Promax 3D Max intended for use in?

The Planmeca Promax 3D Max is specifically designed for dental clinics and oral surgery settings. Its high-resolution 3D imaging capabilities are ideal for assessing dental and skeletal structures, making it particularly useful for diagnostic evaluations and treatment planning in these specialized environments.

Is the Planmeca Promax 3D Max a single-use or reusable device, and what maintenance is required?

The Planmeca Promax 3D Max is a reusable system, not intended for single-use. To ensure accurate imaging and performance, it requires proper calibration and regular maintenance as part of its operational protocol. The device must also be stored in a clean, controlled environment to maintain its standards.

What regulatory pathways has the Planmeca Promax 3D Max followed for approval, and what classification does it hold?

The Planmeca Promax 3D Max has obtained FDA clearance through a 510(k) submission, classified as substantially equivalent under the traditional pathway. In the EU, it complies with both the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), and is categorized as a Class II medical device.

How is the sterility and cleanliness of the Planmeca Promax 3D Max maintained, given it is a reusable system?

Since the Planmeca Promax 3D Max is a reusable system, its sterility and cleanliness are maintained through proper storage in a controlled environment and adherence to manufacturer guidelines for cleaning and maintenance. While it is not single-use, the device must be kept in a sterile or hygienic state to prevent contamination and ensure reliable performance.

What is the primary purpose of the imaging technology in the Planmeca Promax 3D Max, and what anatomical regions does it focus on?

The primary purpose of the Planmeca Promax 3D Max is to capture high-resolution, three-dimensional images of the maxillofacial region. This includes dental structures (such as teeth and jaws) and skeletal components, enabling precise diagnostic assessments and treatment planning for dental and oral surgery procedures.

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 (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Planmeca Oy

Sources (2)

  • FDA 510(k) K093590 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026