Xelis Dental 2.0
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Xelis Dental 2.0 FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Xelis Dental EUDAMED
- Model / Reference
- 602 EUDAMEDXelis Dental 2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809278790307 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809278790307 EUDAMED
- 510(k) Number
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Xelis Dental 2.0 is a dental radiography system, designed for capturing high-resolution images of teeth and oral structures. It employs advanced digital imaging technology to provide clear, detailed visualisations for diagnostic and treatment planning purposes in dental practice.
This device is intended for use in dental clinics and offices, supplied as a standalone system with integrated software for image acquisition and analysis. It is classified under the product code LLZ and has received FDA 510(k) clearance and MDD authorisation, ensuring compliance with regulatory standards for dental imaging equipment. The system is non-sterile and reusable, with no specific MRI safety restrictions noted.
Frequently asked questions
What types of dental images can the Xelis Dental 2.0 capture, and how does its digital technology benefit dental diagnostics?
The Xelis Dental 2.0 is specifically designed to capture high-resolution images of teeth and oral structures, including intraoral and panoramic views. Its advanced digital imaging technology ensures clear, detailed visualizations, which are essential for accurate diagnostics and precise treatment planning in dental practices. The digital format also allows for immediate review, easy storage, and enhanced sharing of images with specialists or patients, improving overall workflow efficiency.
Is the Xelis Dental 2.0 system reusable, and if so, what does that mean for maintenance and cleaning?
Yes, the Xelis Dental 2.0 is a reusable system, meaning it is built to be used repeatedly across multiple patients. Since it is non-sterile, proper cleaning and maintenance protocols must be followed to ensure hygiene and longevity. Clinics should adhere to manufacturer guidelines for disinfection and upkeep to prevent cross-contamination and maintain optimal performance.
What are the key differences between the Xelis Dental 2.0 and traditional film-based dental X-ray systems?
Unlike traditional film-based systems, the Xelis Dental 2.0 uses digital imaging technology, eliminating the need for chemical processing and physical film storage. This makes it more efficient, eco-friendly, and capable of producing immediate, high-resolution images for real-time diagnostics. Additionally, digital images can be easily edited, stored electronically, and shared digitally, reducing administrative burdens and improving patient care.
How is the Xelis Dental 2.0 supplied, and what components are included in the standalone system?
The Xelis Dental 2.0 is supplied as a complete standalone system, which includes the imaging sensor, control unit, and integrated software for capturing and analyzing images. The system is designed for easy setup in dental clinics or offices, ensuring all necessary components for digital radiography are available out of the box without requiring additional purchases.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193369 | Class II | Active |
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Manufacturer
- Manufacturer
- Infinitt Healthcare Co., Ltd.
Sources (3)
- FDA 510(k) K193369 24 fields · synced Sep 18, 2026
- FDA UDI 13b02048-7f22-4fca-81ba-7316ff438c78 33 fields · synced May 30, 2026
- EUDAMED 7c1b4307-b3ba-477d-a08d-3c26390cb9d0 61 fields · synced Jul 18, 2026