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ScanX Edge System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202633

by Dürr Dental Se

Identifiers

510(k) Number
K202633 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 ScanX Edge System is a digital extraoral X-ray imaging device designed for dental applications. It captures and processes radiographic images using Phosphor Storage Plates (PSPs) to produce high-resolution scans of dental structures, supporting diagnostic evaluations in chairside settings.

This device is intended for single-use PSPs and operates in clinical environments such as dental offices. It is classified as a Class II medical device under FDA regulations (510(k) clearance K202633) and is intended for chairside use with intraoral plate sizes 0, 1, and 2. The system is non-reusable and requires proper storage of PSPs to maintain image quality. No specific MRI safety information is provided.

Frequently asked questions

What types of intraoral plates does the ScanX Edge System support for imaging dental structures?

The ScanX Edge System is designed to work with intraoral Phosphor Storage Plates (PSPs) in sizes 0, 1, and 2. These plates are intended for single-use and must be replaced after each imaging session to ensure consistent image quality and hygiene standards.

How should the Phosphor Storage Plates (PSPs) for the ScanX Edge be stored to maintain their functionality?

The Phosphor Storage Plates (PSPs) used with the ScanX Edge System require proper storage to preserve their sensitivity and image quality. They should be kept in a dark, light-tight environment to prevent premature exposure to light, which can degrade their performance. Follow manufacturer guidelines for storage conditions to avoid compromising diagnostic accuracy.

Is the ScanX Edge System reusable, or is it intended for single-use in a clinical setting?

The ScanX Edge System itself is a non-reusable device designed for chairside use in dental offices. However, the key consumable component—the Phosphor Storage Plate (PSP)—is intended for single-use only. This ensures hygiene and reliability for each diagnostic imaging session.

What regulatory pathway was followed for the FDA clearance of the ScanX Edge System?

The ScanX Edge System received FDA clearance through a 510(k) premarket notification process, specifically under the Special 510(k) pathway. It is classified as a Class II medical device and was determined to be substantially equivalent to a legally marketed predicate device, as indicated by the clearance number K202633 and the decision code SESE.

Are there any specific safety considerations for using the ScanX Edge System, such as MRI compatibility?

The ScanX Edge System does not provide explicit MRI safety information in its documentation. Clinicians should exercise caution when handling or storing the device near MRI environments, as standard X-ray imaging equipment may contain metallic components that could pose risks in such settings. Always verify compatibility with your facility’s MRI protocols.

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: ScanX Edge - DÜRR DENTAL SE, ScanX Edge - Air Techniques, ScanX Edge (K202633) — FDA 510(k) | Innolitics, ScanX Edge (K202633) - FDA 510 (k), PDF ScanX Edge

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dürr Dental Se

Sources (1)

  • FDA 510(k) K202633 24 fields · synced Sep 19, 2026