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DXSS AUTOMATIC X-RAY FILM PROCESSOR, - 830

by Dental X-Ray Support Systems, Inc.

510(k) K992896

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992896 Date3 Sep 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EGY
Models / Variants
830)
Device Class
Class II
Regulation
21 CFR Part 892.1900
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DXSS Automatic X-Ray Film Processor is a dental radiographic film processor. Unlike traditional processors that use rollers and gears to transport film through open tanks, this device holds film stationary in a single processing tank.

It is supplied as a reusable device for use in dental radiology settings. The device has FDA 510(k) clearance under K992896 and is classified as a Class II medical device with product code EGY, subject to special controls.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DXSS Automatic X-Ray Film Processor used for?

    The DXSS Automatic X-Ray Film Processor is used to process dental radiographic film in dental radiology settings. It holds film stationary in a single processing tank, unlike traditional roller-based systems, to develop exposed film for diagnostic imaging.

  • Is the DXSS Automatic X-Ray Film Processor reusable or single-use?

    The DXSS Automatic X-Ray Film Processor is supplied as a reusable device. It is designed for repeated use in dental radiology settings, requiring regular maintenance and chemical replenishment for ongoing film processing operations.

  • What models are included in the DXSS Automatic X-Ray Film Processor line?

    The DXSS Automatic X-Ray Film Processor is available in four models: 512, 1530, 812, and 830. These model numbers distinguish the specific configurations within the product line offered by Dental X-Ray Support Systems, Inc.

  • How is the DXSS Automatic X-Ray Film Processor supplied and what are its storage requirements?

    The device is supplied as a reusable unit for installation in dental radiology settings. While specific storage conditions are not detailed in the provided data, as a reusable electronic and mechanical device, it should be stored in a clean, dry environment protected from extreme temperatures and humidity to maintain functionality.