Clear Image Aligners— 510(k) K183643

Substantially Equivalent

Specialty Appliance Works, Inc.

FDA 510(k) clearance K183643 for Clear Image Aligners, Substantially Equivalent on 2019-01-03. Applicant: Specialty Appliance Works, Inc..

Clearance details

Applicant: Specialty Appliance Works, Inc.
Product code: Code NXC
Advisory panel: Dental
Date received: 2018-12-26
Decision date: 2019-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cumming, GA, 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.