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Dvas (dvas-M, Dvas-W)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232085

by Genoray Co., Ltd.

Identifiers

510(k) Number
K232085 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 DVAS (DVAS-M, DVAS-W) is an extraoral X-ray unit designed for dental imaging. It employs a timer function to control exposure duration, ensuring precise radiographic capture for dental diagnostics. This device is classified as a Class II medical device under FDA regulations and is intended for capturing high-quality dental radiographs.

The DVAS is supplied as a reusable dental X-ray system, intended for use in clinical dental settings. It features a temperature-monitoring thermosensor and a color LED indicator to display operational status. The device is regulated under the FDA’s 510(k) pathway and the Medical Device Directive (MDD), with specific compliance to regulation number 872.1800. Storage and maintenance instructions are manufacturer-specific and must be followed to ensure proper functionality and safety.

Frequently asked questions

What types of dental radiographs can the DVAS (DVAS-M, DVAS-W) capture, and how does the timer function help in this process?

The DVAS is an extraoral X-ray unit specifically designed for dental imaging, meaning it captures radiographs outside the mouth, such as panoramic or cephalometric images. The built-in timer function ensures precise control over exposure duration, which is critical for achieving high-quality, clear dental radiographs without overexposure or underexposure. This precision helps in accurately diagnosing dental conditions by providing consistent and reliable imaging results.

Is the DVAS reusable or single-use, and what operational features help ensure its reliability in clinical settings?

The DVAS is designed as a reusable dental X-ray system, intended for long-term use in clinical dental settings. To ensure reliability, it includes a temperature-monitoring thermosensor and a color LED indicator that displays the device’s operational status. These features help monitor performance and alert users to any potential issues, ensuring consistent and safe operation over time.

What regulatory pathways has the DVAS followed, and how does this affect its use in dental practices?

The DVAS has been cleared through the FDA’s 510(k) pathway and complies with the Medical Device Directive (MDD) under regulation number 872.1800. This means it has undergone rigorous evaluation to demonstrate substantial equivalence to existing dental X-ray devices, ensuring it meets safety and performance standards. Clinicians can rely on its regulatory clearance when integrating it into their practice, as it adheres to established guidelines for dental imaging equipment.

Are there specific storage or maintenance instructions provided for the DVAS, and why are they important?

The DVAS requires adherence to manufacturer-specific storage and maintenance instructions, which are essential for preserving its functionality and safety. These guidelines likely cover environmental conditions, cleaning protocols, and periodic checks to prevent malfunctions or damage. Following them ensures the device operates reliably and extends its lifespan, minimizing downtime and maintaining consistent imaging quality in clinical settings.

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: GENORAY Europe

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Genoray Co., Ltd.

Sources (2)

  • FDA 510(k) K232085 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026