U-Aligner— 510(k) K191308

Substantially Equivalent

Universal Orthodontic Laboratory, Inc.

FDA 510(k) clearance K191308 for U-Aligner, Substantially Equivalent on 2020-04-23. Applicant: Universal Orthodontic Laboratory, Inc..

Clearance details

Applicant: Universal Orthodontic Laboratory, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2019-05-14
Decision date: 2020-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CA, 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.