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XERO-alpha

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242591

by DRTECH Corporation

Identifiers

510(k) Number
K242591 FDA 510(k)
FDA Product Code
EHD 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 XERO-alpha is an Extraoral X-Ray Unit With Timer, classified under product code EHD. This device is designed for dental radiography, capturing high-quality images of teeth and surrounding structures using extraoral techniques. Its timer function ensures precise exposure control for consistent imaging results.

Supplied as a reusable Class II medical device, the XERO-alpha is intended for use in dental offices and clinics. It operates under regulatory oversight as defined by 21 CFR 872.1800, with an FDA 510(k) clearance (K242591) granted on November 1, 2024. The device requires proper maintenance and calibration to ensure compliance with safety and performance standards.

Frequently asked questions

What is the primary purpose of the XERO-alpha and how does its timer function contribute to imaging quality?

The XERO-alpha is an extraoral X-ray unit specifically designed for dental radiography, allowing clinicians to capture high-quality images of teeth and surrounding structures. Its built-in timer ensures precise control over exposure time, which helps maintain consistent imaging results by preventing overexposure or underexposure, thereby improving diagnostic accuracy.

Is the XERO-alpha intended for single-use or reusable applications in a clinical setting?

The XERO-alpha is supplied as a reusable Class II medical device, meaning it is designed for repeated use in dental offices and clinics. However, it requires proper maintenance and calibration to ensure ongoing safety and performance compliance with regulatory standards.

What regulatory pathway was followed for the XERO-alpha’s FDA clearance, and what does this mean for its use?

The XERO-alpha received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent under product code EHD for dental radiography. This means the device was determined to have the same intended use, technological characteristics, and performance as a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements for dental X-ray imaging.

Are there multiple models or sizes available for the XERO-alpha, and how might this affect its application?

The provided data lists multiple FEI numbers (e.g., 3013099020, 3003528079), which typically correspond to different configurations or variants of the device. While the exact specifications (e.g., voltage, focal spot size, or physical dimensions) aren’t detailed here, these variations may allow for customization to different dental office setups or patient needs, such as pediatric vs. adult imaging. For precise sizing or model details, consult the manufacturer’s technical documentation.

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: K242591 - XERO-alpha | FDA 510 (k) | DRTECH Corporation, XERO-alpha (K242591) — FDA 510(k) | Innolitics, XERO-alpha - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
DRTECH Corporation

Sources (1)

  • FDA 510(k) K242591 24 fields · synced Sep 19, 2026