FDA applicant
Temrex Corp.
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
How often FDA has decided Temrex Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2007high 1 (2012) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
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.
See the 510(k) Report