Clearform Aligners— 510(k) K191838

Substantially Equivalent

Motor City Lab Works

FDA 510(k) clearance K191838 for Clearform Aligners, Substantially Equivalent on 2020-03-20. Applicant: Motor City Lab Works.

Clearance details

Applicant: Motor City Lab Works
Product code: Code NXC
Advisory panel: Dental
Date received: 2019-07-09
Decision date: 2020-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, MI, 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, 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.