510(k) Report

FDA applicant

Bruxcare, LLC

Houston, TX1 decision1998–19980 recalls

FDA records 1 decision for Bruxcare, LLC (Houston, TX) in 1998: 1 510(k) clearance. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). 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 Bruxcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bruxcare, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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