510(k) Report

FDA applicant

Dentech Corp.

Sumas, WA2 decisions1990–19950 recalls

FDA records 2 decisions for Dentech Corp. (Sumas, WA) from 1990 to 1995: 2 510(k) clearances. Most are in product codes KLC (Chair, Dental, With Operative Unit) and EIA (Unit, Operative Dental). 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 Dentech Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dentech Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dentech 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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