# K173623: Anchor plate

- Pathway: 510(k) (Traditional)
- Applicant: Biomaterials Korea, Inc.
- Decided: Aug 30, 2018 after 279 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- 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: 6 generations back to K954385 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091051: Bollard Miniplate Skeletal Anchorage System, Tita-Link (2009) Summary page 4.

## Indications for use
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.

Source page: https://510kreport.com/device/K173623
Methodology: https://510kreport.com/methodology