FDA applicant
Brux Night Guard
FDA records 1 decision for Brux Night Guard (Canoga Park, CA) in 2019: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). 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 Brux Night Guard’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2019high 1 (2019) · low 0 (2020)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Brux Night Guard’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