# K071490: Leone Orthodontic Mini Implant

- Pathway: 510(k) (Traditional)
- Applicant: Leone S.P.A.
- Decided: Feb 22, 2008 after 268 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: 7 generations back to K894844 (1990). 19 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060126: Absoanchor Microimplant, Dentos, Inc. (2006) Summary page 1.

## Most influential descendants
- K090476: Syntec Orthodontic Mini Screw (2009), 13 descendants of its own
- K110392: PSM Lomas / Benefit Screws (2011), 5 descendants of its own
- K161335: Dual Top Screw System (2017), 3 descendants of its own
- K152297: OBS Anchorage Screw (2016), 1 descendant of its own
- K142001: Syntec Wetali Orthodontic Mini Screws (2015), 1 descendant of its own

## Indications for use
The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.

Source page: https://510kreport.com/device/K071490
Methodology: https://510kreport.com/methodology