# K042345: Lin/Liou Orthodontic Mini Anchor System (Lomas)

- Pathway: 510(k) (Abbreviated)
- Applicant: Mondeal Medical Systems GmbH
- Decided: Jan 13, 2005 after 136 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
- K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device) (2025), 0 descendants of its own
- K231913: T-FIT (2024), 0 descendants of its own
- K210559: ATOZ Mini-Screw (2021), 0 descendants of its own

## Indications for use
The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

Source page: https://510kreport.com/device/K042345
Methodology: https://510kreport.com/methodology