510(k) Report

FDA applicant

Ardent Intl., Inc.

Mchenry, IL3 decisions1984–19860 recalls

FDA records 3 decisions for Ardent Intl., Inc. (Mchenry, IL) from 1984 to 1986: 3 510(k) clearances. Most are in product codes EFH (Paper, Articulation) and DYN (Mouthpiece, Saliva Ejector). 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 Ardent Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ardent Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ardent Intl., 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?

  • EFHPaper, Articulation1decision
  • DYNMouthpiece, Saliva Ejector1decision

What has FDA decided for it lately?

  • K864300Siliva Ejector/Oral Cavity EvacuatorArdent Intl., Inc. · 1986
  • K842512Exacta-FilmArdent Intl., Inc. · 1984
  • K832647Articulating PaperArdent Intl., Inc. · 1984

All 3 as Ardent Intl., Inc. →

Other applicant names beginning “Ardent”

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

Ardent Sound, Inc. 3Ardent Production Development 2Ardent, Inc. 1