K242944

Substantially Equivalent

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

Applicant: Leone S.P.A.
Product code: OAT
Advisory panel: Dental
Date received: 2024-09-25
Decision date: 2025-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sesto Fiorentino, IT

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.