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A/T X-Ray 70

FDA 510(k)

Class II (US FDA 510(k))

510(k) K024285

by Air Techniques, Inc.

Identifiers

510(k) Number
K024285 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 A/T X-Ray 70 is an extraoral dental X-ray unit with a built-in timer, designed for capturing radiographic images of dental structures. It operates as a portable or wall-mounted system, delivering precise imaging for diagnostic purposes in dental settings.

This device is supplied as a reusable medical instrument, intended for use in dental clinics and practices. It is classified under FDA regulation 872.1800 and holds a 510(k) clearance as substantially equivalent to predicate devices. The unit requires proper calibration and maintenance to ensure accurate and safe operation, adhering to standard dental radiography protocols.

Frequently asked questions

What types of dental imaging can the A/T X-Ray 70 capture, and how does its portability benefit dental practices?

The A/T X-Ray 70 is designed specifically for capturing extraoral radiographic images of dental structures, which means it can produce images of teeth, jaws, and surrounding bone outside the mouth. Its portability allows it to be used as either a standalone unit or wall-mounted, making it flexible for different clinic layouts and convenient for capturing images in various patient positions or locations within the practice.

Is the A/T X-Ray 70 intended for single-use or reusable applications, and what maintenance does it require?

The A/T X-Ray 70 is supplied as a reusable medical instrument, meaning it is designed for repeated use in dental clinics. To ensure accurate and safe operation, it requires proper calibration and maintenance, following standard dental radiography protocols. This includes regular checks and servicing to maintain imaging precision and compliance with safety standards.

What regulatory pathway was followed for the approval of the A/T X-Ray 70, and what does this mean for its use in dental settings?

The A/T X-Ray 70 received FDA clearance through a 510(k) submission, determined to be substantially equivalent to predicate devices under FDA regulation 872.1800. This means the device meets the necessary safety and performance standards for use in dental settings, adhering to established guidelines for extraoral X-ray units with timers. Clinicians can rely on its compliance with these regulatory requirements for diagnostic imaging.

How does the built-in timer in the A/T X-Ray 70 contribute to the imaging process?

The built-in timer in the A/T X-Ray 70 ensures precise control over exposure time during radiographic imaging. This feature helps standardize image quality by preventing overexposure or underexposure, which is critical for accurate diagnosis of dental structures. Consistent exposure times improve reproducibility and reliability of the images captured.

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: Provecta 70 Mobile Intraoral X-Ray Operator's Manual | Manualzz, Provecta 70 Intraoral Dental X-ray Machine from Air Techniques, Inc., PROVECTA 70 - Air Techniques - ManualZilla

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Air Techniques, Inc.

Sources (1)

  • FDA 510(k) K024285 24 fields · synced Sep 18, 2026