ZSmile System— 510(k) K253282

Substantially Equivalent

Dror Orthodesign , Ltd.

FDA 510(k) clearance K253282 for ZSmile System, Substantially Equivalent on 2026-02-03. Applicant: Dror Orthodesign , Ltd..

Clearance details

Applicant: Dror Orthodesign , Ltd.
Product code: Code NXC
Advisory panel: Dental
Date received: 2025-09-29
Decision date: 2026-02-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Jerusalem, IL

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.