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Dental CT Scanner AXR

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223816

by Alliage S/A Indústrias Médico Odontológica

Identifiers

510(k) Number
K223816 FDA 510(k)
FDA Product Code
OAS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dental CT Scanner AXR is a computed tomography device designed specifically for dental imaging. It generates detailed cross-sectional images of dental structures, including teeth, jawbones, and surrounding tissues, enabling precise diagnosis and treatment planning in endodontics, orthodontics, and oral surgery.

This device is intended for use in dental clinics and oral healthcare settings. Supplied as a reusable medical instrument, it operates under FDA clearance (K223816) as a Class 2 Radiology device with product code OAS. The scanner adheres to regulatory standards outlined in 21 CFR Part 807 and 21 CFR 892.1750, ensuring compliance with safety and performance requirements for dental radiographic equipment.

Frequently asked questions

How is the Dental CT Scanner AXR intended to be used in a dental clinic setting?

The Dental CT Scanner AXR is designed for detailed imaging of dental structures, including teeth, jawbones, and surrounding tissues. It supports precise diagnosis and treatment planning in specialties like endodontics, orthodontics, and oral surgery by generating cross-sectional images. The device is specifically meant for use in dental clinics and oral healthcare environments where high-resolution radiographic imaging is required.

Is the Dental CT Scanner AXR a single-use or reusable device?

The Dental CT Scanner AXR is supplied as a reusable medical instrument. This means it is built for repeated use in clinical settings after proper cleaning, maintenance, and sterilization procedures, ensuring long-term reliability and cost-effectiveness for dental practices.

What regulatory pathway was followed for the FDA clearance of the Dental CT Scanner AXR?

The Dental CT Scanner AXR received FDA clearance under the 510(k) pathway, specifically classified as an Abbreviated submission with a Substantially Equivalent determination. It was reviewed by the Radiology (RA) Advisory Committee and falls under product code OAS, aligning with Class 2 Radiology device standards. The clearance number is K223816, and it complies with 21 CFR Part 807 and 21 CFR 892.1750 for dental radiographic equipment.

What types of dental imaging does the Dental CT Scanner AXR provide?

The Dental CT Scanner AXR generates computed tomography (CT) images, producing detailed cross-sectional views of dental anatomy. This includes high-resolution scans of teeth, jawbones, and surrounding soft tissues, enabling clinicians to assess complex cases in endodontics, orthodontics, and oral surgery with enhanced diagnostic clarity.

Does the Dental CT Scanner AXR come with multiple models or configurations?

The provided data lists multiple FEI numbers (e.g., 3009717300, 3012957335, etc.), which typically correspond to different configurations, software versions, or regional adaptations of the scanner. While the exact variations aren’t detailed, these identifiers suggest the device may offer flexibility in terms of technical specifications or regional compliance. For precise model details, consulting the manufacturer’s documentation or support team is recommended.

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: PDF Alliage S/A Industrias Medico Odontológica. ℅ Daniel Kamm Principal ..., Dental CT Scanner AXR (K223816) — FDA 510 (k) | Innolitics, K223816 FDA 510 (k) - Dental CT Scanner AXR, PDF Alliage S/A Industrias Medico Odontológica. ℅ Daniel Kamm Principal ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alliage S/A Indústrias Médico Odontológica
FDA Applicant
Alliage S/A Industrias Medico Odontológica

Sources (1)

  • FDA 510(k) K223816 24 fields · synced Oct 6, 2026