DeviceClearance

K181361

Substantially Equivalent

Brux Night Guard

Applicant
Brux Night Guard
Product code
MQC
Advisory panel
Unknown
Date received
Decision date
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, through . 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.