Oniris; Oniris Plus— 510(k) K250353

Substantially Equivalent

Oniris

FDA 510(k) clearance K250353 for Oniris; Oniris Plus, Substantially Equivalent on 2025-09-04. Applicant: Oniris.

Clearance details

Applicant: Oniris
Product code: Code LRK
Advisory panel: Dental
Date received: 2025-02-07
Decision date: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rueil Malmaison, FR

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.