SunClear Aligner system— 510(k) K190394

Substantially Equivalent

Sun Dental Laboratories, LLC

FDA 510(k) clearance K190394 for SunClear Aligner system, Substantially Equivalent on 2019-12-16. Applicant: Sun Dental Laboratories, LLC.

Clearance details

Applicant: Sun Dental Laboratories, LLC
Product code: Code NXC
Advisory panel: Dental
Date received: 2019-02-19
Decision date: 2019-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, 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.