510(k) Report

FDA applicant

Dent-X Co.

Elmsford, NY1 decision1987–19870 recalls

FDA records 1 decision for Dent-X Co. (Elmsford, NY) in 1987: 1 510(k) clearance. All are in product code EGY (Processor, Radiographic-Film, Automatic, Dental). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Dent-X Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dent-X Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Dent-X Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dent-X Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EGYProcessor, Radiographic-Film, Automatic, Dental1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K874118Model 410 Dental X-Ray Film ProcessorsDent-X Co. · 19872cite it

What has FDA decided for it lately?

  • K874118Model 410 Dental X-Ray Film ProcessorsDent-X Co. · 1987

The one decision as Dent-X Co. →

Other applicant names beginning “Dent-X”

FDA records each applicant name separately; these may or may not be the same firm.

Dent Zar, Inc. 12Dent Corp. Research & Development 3Dent-Dr. 1Dent'N CO 1