Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Leone S.P.A. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | Leone S.P.A. | 2025-06-19 | 267 | 0 |
| K071490 | LEONE ORTHODONTIC MINI IMPLANT | Leone S.P.A. | 2008-02-22 | 268 | 0 |
| K070483 | LEONE MONOIMPLANT FOR O-RING OVERDENTURE | Leone S.P.A. | 2007-04-19 | 58 | 0 |
| K050586 | LEONE IMPLANT SYSTEM | Leone S.P.A. | 2006-02-27 | 357 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda