510(k) Report

FDA applicant

Imd, Inc.

Franklin Lakes, NJ4 decisions1986–20120 recalls

FDA records 4 decisions for Imd, Inc. (Franklin Lakes, NJ) from 1986 to 2012: 4 510(k) clearances. Most are in product codes EJR (Agent, Polishing, Abrasive, Oral Cavity) and CAZ (Anesthesia Conduction Kit). Its devices cite 2 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 Imd, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Imd, Inc.’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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Which product codes does it file in?

  • EJRAgent, Polishing, Abrasive, Oral Cavity3decisions
  • CAZAnesthesia Conduction Kit1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K113662Fenestrated Nerve Block NeedleImd, Inc. · 2012
  • K865082Prophy Care SolutionImd, Inc. · 1987
  • K864215Prophy Care SolutionImd, Inc. · 1986
  • K863133Prophy Care PasteImd, Inc. · 1986

All 4 as Imd, Inc. →