510(k) Report

FDA applicant

Glenroe Technologies

Bradenton, FL9 decisions1992–19980 recalls

FDA records 9 decisions for Glenroe Technologies (Bradenton, FL) from 1992 to 1998: 9 510(k) clearances. Most are in product codes ECI (Band, Elastic, Orthodontic) and ECS (Pusher, Band, Orthodontic). No recall is linked to its devices.

FDA’s records also spell it “Glenroe Technologies, Inc.”.

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 Glenroe Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glenroe Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Glenroe”

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