Fas Aligner System— 510(k) K242929

Substantially Equivalent

Xplora 3D Europe S.L

FDA 510(k) clearance K242929 for Fas Aligner System, Substantially Equivalent on 2024-12-20. Applicant: Xplora 3D Europe S.L.

Clearance details

Applicant: Xplora 3D Europe S.L
Product code: Code NXC
Advisory panel: Dental
Date received: 2024-09-24
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

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.