Clear Aligner— 510(k) K203688

Substantially Equivalent

Wuxi EA Medical Instruments Technologies Limited.

FDA 510(k) clearance K203688 for Clear Aligner, Substantially Equivalent on 2021-10-08. Applicant: Wuxi EA Medical Instruments Technologies Limited..

Clearance details

Applicant: Wuxi EA Medical Instruments Technologies Limited.
Product code: Code NXC
Advisory panel: Dental
Date received: 2020-12-17
Decision date: 2021-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

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.