Dental Extraoral Source X-ray System (ESX)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K092103 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 Dental Extraoral Source X-ray System (ESX) is an AC-powered device that produces x-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. It is designed to provide diagnostic dental radiographs for the treatment of dental conditions.
The ESX is intended for single-use and is supplied sterile. It operates as a Class II device under FDA 510(k) clearance (K092103) and is regulated under 21 CFR 872.1800. Proper storage and handling are required to maintain device integrity.
Frequently asked questions
What is the Dental Extraoral Source X-Ray System (ESX) used for?
The ESX is an AC-powered device designed to produce x-rays for dental radiographic examinations. It is intended to help diagnose diseases of the teeth, jaw, and other oral structures.
Is the ESX device sterile and intended for single use?
Yes, the ESX is supplied sterile and is intended for single use. Proper storage and handling are required to maintain the device's integrity.
What is the regulatory status of the Dental Extraoral Source X-Ray System?
The ESX is a Class II device cleared by the FDA under 510(k) clearance (K092103) and is regulated under 21 CFR 872.1800.
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: Dental Extraoral Source X-ray System (Esx), Dental - VATECH, PDF K092103 - Dental Extraoral Source X-ray System (Esx), PDF 510(k) Summary OCT -9 '?nnf9 - Food and Drug Administration, VATECH
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092103 | Class II | Active |
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Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (1)
- FDA 510(k) K092103 24 fields · synced Sep 25, 2026