Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233395 FDA 510(k)
- FDA Product Code
- EHD FDA 510(k)
- Models / Variants
- Portable Dental X-Ray (AXR60 S) FDA 510(k)Portable Dental X-Ray (AXR65 S) 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 Portable Dental X-Ray (AXR60 S) and (AXR65 S) are classified as Unit, X-Ray, Extraoral With Timer, designed for dental radiographic examinations. These devices generate X-rays to diagnose dental and oral conditions, including teeth, jaw, and surrounding structures, using an extraoral X-ray source positioned outside the mouth.
These portable systems are intended for use by trained dentists or dental technicians in clinical settings. Supplied as reusable medical devices, they require compliance with regulatory standards, including FDA 510(k) clearance under K233395. The units are AC-powered and include patient and equipment supports, adhering to Class II (EHD) regulatory classification under regulation number 872.1800.
Frequently asked questions
Are these portable dental X-ray devices single-use or reusable, and what does that mean for maintenance and cleaning?
The Portable Dental X-Ray (AXR60 S) and (AXR65 S) are reusable medical devices. As reusable equipment, they require proper cleaning, disinfection, and maintenance between uses to ensure safety and functionality. The manufacturer’s instructions should be followed for sterilization protocols, as these devices are not designed for single-use. Regular servicing is also necessary to maintain performance and compliance with regulatory standards.
What types of dental and oral conditions can these X-ray devices diagnose, and how does the extraoral positioning help?
These devices are designed for dental radiographic examinations, specifically to diagnose conditions involving teeth, jaws, and surrounding oral structures. The extraoral positioning of the X-ray source means the device is placed outside the mouth, allowing for imaging of larger areas, such as the temporomandibular joint (TMJ), sinus regions, or full-arch evaluations. This positioning can provide clearer images of complex anatomical features that intraoral devices may miss.
How are these devices powered, and what accessories are included to support patient positioning during use?
The Portable Dental X-Ray (AXR60 S) and (AXR65 S) are AC-powered, meaning they require a standard electrical outlet for operation. The units come equipped with patient and equipment supports, which help stabilize both the patient and the device during imaging. These supports ensure proper alignment and positioning for consistent, high-quality radiographs.
What regulatory pathway was followed for FDA clearance, and how does this classification impact clinical use?
These devices underwent an FDA 510(k) clearance process under the classification Unit, X-Ray, Extraoral With Timer, with the clearance type labeled as Abbreviated (SESE). This means the manufacturer demonstrated that their device is substantially equivalent to a legally marketed predicate device, ensuring compliance with safety and performance standards. Clinically, this classification confirms the device meets Class II (EHD) regulatory requirements, which governs its use in dental settings for radiographic examinations.
Are there different models available, and if so, how do they differ in terms of functionality or intended use?
Yes, there are two models: the AXR60 S and the AXR65 S, both classified as Unit, X-Ray, Extraoral With Timer. While the exact functional differences between the two models are not specified in the provided data, their shared classification and regulatory pathway suggest they serve similar purposes—dental radiographic examinations—with potential variations in technical specifications (e.g., image resolution, timer settings, or portability features). For precise differences, refer to the manufacturer’s documentation.
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: Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S ..., PDF January 3, 2024 Alliage S/A Industrias Médico Odontológica ℅ Daniel ..., K233395 - Portable Dental X-Ray (AXR60 S) - Radiology
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233395 | Class II | Active |
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Manufacturer
- Manufacturer
- Alliage S/A Indústrias Médico Odontológica
- FDA Applicant
- Alliage S/A Industrias Médico Odontológica
Sources (1)
- FDA 510(k) K233395 24 fields · synced Oct 6, 2026