# K033767: Dual Top Anchor System Screws

- Pathway: 510(k) (Traditional)
- Applicant: Jeil Medical Corporation
- Decided: Feb 24, 2004 after 83 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
Longest line of descent: 4 generations back to K894844 (1990). 15 ancestors in all.
54 later devices descend from it; 17 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031936: Osteomed Orthodontic Screw System, Osteomed LP (2004). Cleared while this submission was under review Summary page 1.
- K982509: Ortho Implant and Accessories, Straumann USA (1998) Summary page 1.
- K000643: Inplant Orthodontic Anchor System, Nobel Biocare Uas, Inc. (2000) Summary page 1.

## Most influential descendants
- K042965: Tomas Pin (2005), 26 descendants of its own
- 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
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own

## Indications for use
This device is intended 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. Screws are intended for single use only. For use on adults over the age of 12.

Source page: https://510kreport.com/device/K033767
Methodology: https://510kreport.com/methodology