# K042289: Mdi Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Sep 15, 2004 after 22 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 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
- K060126: Absoanchor Microimplant (2006), 19 descendants of its own
- K071490: Leone Orthodontic Mini Implant (2008), 14 descendants of its own
- 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

## Indications for use
Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Implants are intended for single use only.

Source page: https://510kreport.com/device/K042289
Methodology: https://510kreport.com/methodology