510(k) Report

FDA applicant

Stratum Dental Technologies, Inc.

Las Vegas, NV1 decision1993–19930 recalls

FDA records 1 decision for Stratum Dental Technologies, Inc. (Las Vegas, NV) in 1993: 1 510(k) clearance. All are in product code EJL (Bur, 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 Stratum Dental Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stratum Dental Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stratum Dental Technologies, 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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