510(k) Report

FDA applicant

Sterndent Corp.

Mchenry, IL2 decisions1977–19770 recalls

FDA records 2 decisions for Sterndent Corp. (Mchenry, IL) in 1977: 2 510(k) clearances. Most are in product codes ELZ (Crown, Preformed) and KZN (Scanner, Color). 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 Sterndent Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterndent Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sterndent Corp.’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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