DeviceClearance

Custom Clear Aligner System— 510(k) K173785

Substantially Equivalent

Derby Dental Laboratory

FDA 510(k) clearance K173785 for Custom Clear Aligner System, Substantially Equivalent on 2018-03-13. Applicant: Derby Dental Laboratory.

Clearance details

Applicant
Derby Dental Laboratory
Product code
Code NXC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Louisville, KY, US
Download summary PDFView 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.