# K133178: Luxator LX Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Directa AB
- Decided: Nov 24, 2015 after 768 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is designed to expand the tooth socket by widening the gap between root and bone to facilitate tooth removal due to caries, trauma, orthodontic reasons.

Source page: https://510kreport.com/device/K133178
Methodology: https://510kreport.com/methodology