Leone Orthodontic Implant TAD (Temporary Anchorage Device)— 510(k) K242944
Substantially EquivalentLeone S.P.A.
FDA 510(k) clearance K242944 for Leone Orthodontic Implant TAD (Temporary Anchorage Device), Substantially Equivalent on 2025-06-19. Applicant: Leone S.P.A..
Clearance details
- Applicant
- Leone S.P.A.
- Product code
- Code OAT
- Advisory panel
- Dental
- Date received
- Decision date
- 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, through . 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.