510(k) Report

FDA applicant

Temrex Corp.

Freeport, NY2 decisions1985–20120 recalls

FDA records 2 decisions for Temrex Corp. (Freeport, NY) from 1985 to 2012: 2 510(k) clearances. Most are in product codes EMA (Cement, Dental) and LBH (Varnish, Cavity). 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 Temrex Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Temrex 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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