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Endograph DC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130109

by Villa Sistemi Medicali S.p.a.

Identifiers

510(k) Number
K130109 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 Endograph DC is an Extraoral X-Ray Unit with Timer, designed for dental radiography. It is classified as a Class II medical device and is intended for capturing radiographic images of dental structures, including periapical, bitewing, and panoramic views, using extraoral techniques. The device incorporates high-frequency technology to ensure precise imaging while minimizing patient exposure to radiation.

This device is supplied as a reusable, non-sterile system intended for use in dental clinics and oral healthcare settings. It operates with standard electrical power and includes a control unit with a large display for user interaction. The Endograph DC has received FDA 510(k) clearance under the Abbreviated pathway, with a decision code of SESE (Substantially Equivalent). No specific MRI safety classification or sterility requirements are noted in the regulatory data.

Frequently asked questions

What types of dental images can the Endograph DC capture, and how does its high-frequency technology benefit patients?

The Endograph DC is designed to capture extraoral radiographic images of dental structures, including periapical, bitewing, and panoramic views. Its high-frequency technology ensures precise imaging while significantly reducing patient radiation exposure, which helps minimize risks associated with dental X-rays.

Is the Endograph DC reusable or single-use, and what are the sterility requirements for its use?

The Endograph DC is supplied as a reusable system and is explicitly labeled as non-sterile. Since it is not intended for sterile procedures, no sterility requirements are specified in the regulatory data, but standard infection control protocols for reusable medical devices should be followed.

How is the Endograph DC powered, and what key features does its control unit include?

The Endograph DC operates using standard electrical power. Its control unit features a large display for user interaction, allowing clinicians to easily adjust settings and review captured images during dental radiography.

What regulatory pathway was used for FDA clearance of the Endograph DC, and what does this mean for its equivalence to prior devices?

The Endograph DC received FDA 510(k) clearance under the Abbreviated pathway, with a decision code of SESE (Substantially Equivalent). 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 established safety and effectiveness standards.

Are there any specific storage requirements mentioned for the Endograph DC, and how should it be maintained?

The provided regulatory data does not specify detailed storage requirements for the Endograph DC beyond standard environmental conditions for medical imaging equipment. However, since it is reusable, it should be cleaned and maintained according to manufacturer guidelines to ensure optimal performance and longevity.

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: ENDOGRAPH DC User's Manual | Manualzz, Endograph DC - IDS Dental, Systems for Medical Applications - VILLA SISTEMI MEDICALI

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Villa Sistemi Medicali S.p.a.

Sources (1)

  • FDA 510(k) K130109 24 fields · synced Sep 20, 2026