Brux Night Guard— 510(k) K181361

Substantially Equivalent

Brux Night Guard

FDA 510(k) clearance K181361 for Brux Night Guard, Substantially Equivalent on 2019-04-11. Applicant: Brux Night Guard.

Clearance details

Applicant: Brux Night Guard
Product code: Code MQC
Advisory panel: Unknown
Date received: 2018-05-23
Decision date: 2019-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canoga Park, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.