K242944
- 510(k) number
- K242944
- Device name
- Leone Orthodontic Implant TAD (Temporary Anchorage Device)
- Applicant
- Leone S.P.A. IT
- Product code
- OAT — Implant, Endosseous, Orthodontic
- Decision date
- 2025-06-19
- Date received
- 2024-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K242944.pdf
Official FDA record: K242944
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.