# K090476: Syntec Orthodontic Mini Screw

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Jun 18, 2009 after 114 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: 8 generations back to K894844 (1990). 20 ancestors in all.
13 later devices descend from it; 6 cite 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)
- K071490: Leone Orthodontic Mini Implant, Leone S.P.A. (2008) Summary page 2.

## Most influential descendants
- 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
- K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device) (2025), 0 descendants of its own

## Indications for use
The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Source page: https://510kreport.com/device/K090476
Methodology: https://510kreport.com/methodology