Panoramic X-Ray System Model A

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K772164 ↗

FDA Product Code

EHD

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Sybron Corp. →

• What is the Sybron Panoramic X-Ray System Model A used for?

  The Sybron Panoramic X-Ray System Model A is designed specifically for dental professionals to obtain comprehensive panoramic radiographs of the maxillofacial region. This includes imaging the teeth, jaws, nasal cavities, and sinuses in a single exposure, eliminating the need for multiple individual X-rays. It aids in diagnosing dental and skeletal conditions by providing a complete view of the oral and maxillofacial structures.

• How is the Sybron Panoramic X-Ray System Model A supplied and maintained?

  The Sybron Panoramic X-Ray System Model A is supplied as a reusable medical device, meaning it is intended for repeated use in dental offices and clinics. Proper maintenance, including regular calibration, is essential to ensure accurate imaging and compliance with radiation safety protocols. The device is not sterile, so it must be handled and cleaned according to standard infection control practices for reusable medical equipment.

• Is the Sybron Panoramic X-Ray System Model A single-use or reusable?

  The Sybron Panoramic X-Ray System Model A is explicitly designed as a reusable device. Unlike single-use items, it requires ongoing maintenance, cleaning, and calibration to function safely and effectively. This classification aligns with its intended use in clinical settings where durability and repeated use are necessary.

• What installation considerations should be made for the Sybron Panoramic X-Ray System Model A?

  Historical marketing materials for the Sybron Panoramic X-Ray System Model A reference floor mounting as the typical installation method. While the current specifications do not explicitly confirm this, floor mounting is likely the standard approach to ensure stability and proper positioning for panoramic imaging. Installation should adhere to manufacturer guidelines and local regulations to ensure safety and optimal performance.

• Does the Sybron Panoramic X-Ray System Model A have any special storage requirements?

  Since the Sybron Panoramic X-Ray System Model A is a reusable and non-sterile device, its storage should follow general guidelines for medical imaging equipment. It should be kept in a clean, dry environment protected from physical damage, extreme temperatures, and direct sunlight. Additionally, storage areas should be secure to prevent unauthorized access and ensure compliance with radiation safety protocols.