# K260268: OrthoEasy Pal; OrthoEasy Pal Long Neck

- Pathway: 510(k) (Traditional)
- Applicant: Bernhard Förster GmbH (Bernhard Foerster Ltd.)
- Decided: May 19, 2026 after 111 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: 7 generations back to K894844 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110275: Ortho Easy Pin, Forestadent Bernhard Forster GmbH (2011) Summary page 5.

## Indications for use
FORESTADENT OrthoEasy® anchorage screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. The device is not intended for palatal expansion or for use as a prosthodontic or dental implant component.

Source page: https://510kreport.com/device/K260268
Methodology: https://510kreport.com/methodology