510(k) Report

FDA applicant

Prometex, Inc.

Houston, TX4 decisions1987–19900 recalls

FDA records 4 decisions for Prometex, Inc. (Houston, TX) from 1987 to 1990: 4 510(k) clearances. Most are in product codes EBG (Crown And Bridge, Temporary, Resin) and EWO (Audiometer). 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 Prometex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prometex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Prometex, 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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