FDA applicant

Health-Dent Intl., Inc.

Northlake, IL8 decisions1995–19970 recalls

FDA records 8 decisions for Health-Dent Intl., Inc. (Northlake, IL) from 1995 to 1997: 8 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and KLE (Agent, Tooth Bonding, Resin). 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 Health-Dent Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health-Dent Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Health-Dent Intl., Inc.

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?