Class Class II
Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944)
Description
Leone Orthodontic Implant TAD (Temporary Anchorage Device) by Leone S.P.A., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242944
Clearance Date2025-06-19
Clearance TypeTraditional
Product CodeOAT
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242944
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K110392 | PSM LOMAS / BENEFIT SCREWS | Psm Medical Solutions | 2011 |
| K070483 | LEONE MONOIMPLANT FOR O-RING OVERDENTURE | Leone S.P.A. | 2007 |
Trace the full predicate network for K242944
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.