# K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device)

- Pathway: 510(k) (Traditional)
- Applicant: Leone S.P.A.
- Decided: Jun 19, 2025 after 267 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894844 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110392: PSM Lomas / Benefit Screws, Psm Medical Solutions (2011) Summary page 5.

## Indications for use
The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Source page: https://510kreport.com/device/K242944
Methodology: https://510kreport.com/methodology