# K000643: Inplant Orthodontic Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Sep 7, 2000 after 195 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.
64 later devices descend from it; 6 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031936: Osteomed Orthodontic Screw System (2004), 63 descendants of its own
- K033767: Dual Top Anchor System Screws (2004), 54 descendants of its own
- 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

Source page: https://510kreport.com/device/K000643
Methodology: https://510kreport.com/methodology