Dental Xeroradiography

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

510(k) Number

K791014 ↗

FDA Product Code

EAP

Device Class

Class II

Regulation

21 CFR Part 872.1810

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Xeroradiography Liquid Toner Imaging System

  Class II

  FDA 510(k) K853459 Active Cleared 30 Oct 1985

• Xerox 128 Cassette Changer

  Class II

  FDA 510(k) K812024 Active Cleared 13 Aug 1981

• Xerox 120 Sys Mammographic X-Ray

  Class II

  FDA 510(k) K832733 Active Cleared 29 Sep 1983

• Mammographic S-Ray System

  Class II

  FDA 510(k) K833243 Active Cleared 28 Oct 1983

• What is the Dental Xeroradiography device used for?

  The Dental Xeroradiography is a unit for X-Ray imaging specifically designed for intraoral use. It produces dental images using xeroradiographic technology adapted for dental applications including cephalometry, sialography, and panoramic imaging.

• How is the Dental Xeroradiography device supplied?

  The device is supplied by Xerox Medical Systems. It has FDA 510(k) clearance with product code EAP and is classified as a Class II device regulated under number 872.1810.

• Is the Dental Xeroradiography device single-use or reusable?

  The device information does not specify whether it is single-use or reusable. It is designed for dental imaging applications and was cleared on September 4, 1979, with multiple registration numbers.

• What are the regulatory details for the Dental Xeroradiography device?

  The device has FDA 510(k) clearance with product code EAP and is classified as a Class II device regulated under number 872.1810. It was cleared on September 4, 1979, and has multiple registration numbers including 3011471624, 3013511605, and others.