FDA applicant

Dentsply Gendex

Des Plaines, IL1 decision2003–20031 recall

FDA records 1 decision for Dentsply Gendex (Des Plaines, IL) in 2003: 1 510(k) clearance. All are in product code EHD (Unit, X-Ray, Extraoral With Timer). 1 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, dental panel, where it files most

How often FDA has decided Dentsply Gendex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentsply Gendex since 2007.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Dentsply”

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

Dentsply Intl. 291 Dentsply Sirona 88 Dentsply International, Inc. 59 Dentsply Interntional 13 Dentsply Midwest 1 Dentsply Implant 1 Dentsply Implants Manufacturing GmbH 1 Dentsply Ceramco 1

Dentsply Gendex

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Dentsply”