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Eagle Edge AXR90 and AXR120

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210820

by Alliage S/A Indústrias Médico Odontológica

Identifiers

510(k) Number
K210820 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 Eagle Edge AXR90 and AXR120 are computed tomography x-ray systems designed for dental imaging. These devices provide high-resolution, three-dimensional imaging to capture detailed views of dental structures, including teeth, jaws, and surrounding anatomy, enabling precise diagnostic and treatment planning in radiology.

Supplied as a complete 4-in-1 dental imaging system, the AXR90 and AXR120 are intended for use in dental and radiology settings. They are classified as Class II devices under 21 CFR 892.1750 and have received FDA 510(k) clearance (K210820) as substantially equivalent to a predicate device. The systems are not specified as single-use or reusable, nor are MRI safety details provided in the data.

Frequently asked questions

What types of dental structures can the Eagle Edge AXR90 and AXR120 capture in 3D imaging, and how does this benefit diagnostic and treatment planning?

The Eagle Edge AXR90 and AXR120 are computed tomography x-ray systems designed specifically for dental imaging, allowing them to capture high-resolution, three-dimensional views of teeth, jaws, and surrounding anatomical structures. This detailed imaging supports precise diagnostic evaluations and enhances treatment planning by providing clear, volumetric data for procedures like implantology, orthodontics, and endodontics.

Are the Eagle Edge AXR90 and AXR120 systems intended for single-use or reusable applications, and what does this mean for maintenance?

The provided data does not specify whether the Eagle Edge AXR90 and AXR120 are single-use or reusable. If reusable, they would require regular maintenance and sterilization protocols to ensure safety and performance. If single-use, they would be designed for one-time use only, reducing maintenance needs but increasing disposal considerations. Clarification from the manufacturer would be necessary for proper facility planning.

What regulatory pathway was followed for FDA clearance of the Eagle Edge AXR90 and AXR120, and what does this mean for compliance?

The Eagle Edge AXR90 and AXR120 were cleared through the FDA’s 510(k) pathway, specifically as an abbreviated submission (K210820) under 21 CFR 892.1750, with a decision of substantial equivalence to a predicate device. This means the manufacturer demonstrated that the new device is as safe and effective as an existing, legally marketed device, ensuring compliance with FDA standards for computed tomography dental x-ray systems.

How are the Eagle Edge AXR90 and AXR120 systems supplied, and what should a facility expect when integrating them into a dental or radiology setting?

The Eagle Edge AXR90 and AXR120 are supplied as complete 4-in-1 dental imaging systems, meaning they include all necessary components for operation in a single package. Facilities integrating these systems should expect a streamlined setup process, as they are designed for use in both dental and radiology environments, though specific installation requirements (e.g., power, connectivity, or space) should be confirmed with the manufacturer’s guidelines.

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: EAGLE EDGE AXR90 and AXR120 (K210820) — FDA 510(k) | Innolitics, PDF Alliage S/A Industrias Medico Odontológica. ℅ Daniel Kamm Principal ..., PDF August 10, 2021 Alliage S/A Industrias Médico Odontológica Mr. Daniel ...

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) K210820 24 fields · synced Oct 6, 2026