FDA applicant

Cortex Dental Implants Industries, Ltd.

Shlomi, IL4 decisions2009–20190 recalls

FDA records 4 decisions for Cortex Dental Implants Industries, Ltd. (Shlomi, IL) from 2009 to 2019: 4 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, dental panel, where it files most

How often FDA has decided Cortex Dental Implants Industries, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Cortex Dental Implants Industries, Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Cortex”

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

Cortex Manufacturing, Inc. 3 Cortex, Inc. 2 Cortex Biophysik GmbH 2 Cortex Technology Aps 2 Cortex Research Corp. 1

Cortex Dental Implants Industries, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cortex”