# K053629: Anchor Plus/Neo Anchor Plus

- Pathway: 510(k) (Traditional)
- Applicant: Kj Meditech
- Decided: May 31, 2006 after 153 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: 5 generations back to K894844 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000643: Inplant Orthodontic Anchor System, Nobel Biocare Uas, Inc. (2000) Summary page 1.
- K033767: Dual Top Anchor System Screws, Jeil Medical Corporation (2004) Summary page 1.

## 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 for anchorage and is removed after orthodontic treatment has been completed. Screws are intended for single use only

Source page: https://510kreport.com/device/K053629
Methodology: https://510kreport.com/methodology