510(k) Report

FDA applicant

Dentec, Inc.

Walker, MI3 decisions1983–19900 recalls

FDA records 3 decisions for Dentec, Inc. (Walker, MI) from 1983 to 1990: 3 510(k) clearances. Most are in product codes EAX (Mirror, Mouth) and ETN (Stimulator, Nerve). 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 Dentec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dentec, 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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