Leone Orthodontic Implant TAD (Temporary Anchorage Device)— 510(k) K242944

Name: FDA 510(k) clearance K242944
Creator: U.S. Food and Drug Administration
Published: 2025-06-19

Substantially Equivalent

Leone 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.. Device class: 2.

Clearance details

Applicant: Leone S.P.A.
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2024-09-25
Decision date: 2025-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sesto Fiorentino, IT

Download summary PDF View on FDA.gov ↗

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K202163 — Mico One Orthodontic Screw2022-10-07

More clearances from Leone S.P.A.

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K071490 — LEONE ORTHODONTIC MINI IMPLANT2008-02-22
K070483 — LEONE MONOIMPLANT FOR O-RING OVERDENTURE2007-04-19
K050586 — LEONE IMPLANT SYSTEM2006-02-27

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.