510(k) Report

FDA applicant

Crx Medical, Inc.

Raleigh, NC2 decisions1989–19900 recalls

FDA records 2 decisions for Crx Medical, Inc. (Raleigh, NC) from 1989 to 1990: 2 510(k) clearances. All are in product code EMA (Cement, 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, dental panel, where it files most

How often FDA has decided Crx Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Crx Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • EMACement, Dental2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K902078Add'l Indication for Octyldent 2-Octyl Cranoacry.Crx Medical, Inc. · 19901cites it

What has FDA decided for it lately?

  • K902078Add'l Indication for Octyldent 2-Octyl Cranoacry.Crx Medical, Inc. · 1990
  • K884652OctyldentCrx Medical, Inc. · 1989

All 2 as Crx Medical, Inc. →