DeviceClearance

K192338

Substantially Equivalent

NEOLab Clear Aligners

Applicant
New England Ortho Lab, Inc.
Product code
NXC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Andover, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NXC

product code NXC
Injury
15,206
Malfunction
2,576
Other
9
Total
17,791

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.