Twilite Appliance— 510(k) K190687

Substantially Equivalent

Stephen J Harkins, Dds, PC

FDA 510(k) clearance K190687 for Twilite Appliance, Substantially Equivalent on 2019-07-02. Applicant: Stephen J Harkins, Dds, PC.

Clearance details

Applicant: Stephen J Harkins, Dds, PC
Product code: Code LRK
Advisory panel: Dental
Date received: 2019-03-18
Decision date: 2019-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.