# K232551: EM-07 Cordless Endo Motor

- Pathway: 510(k) (Traditional)
- Applicant: Forum Engineering Technologies (96), Ltd.
- Decided: Jul 9, 2024 after 321 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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
The EM-07 is a cordless handpiece with apex localization capability, used for driving files in both continuous rotation and reciprocating mode during an endodontic procedure for enlargement of root canals, while monitoring the position of the endodontic file tip within the canal.

Source page: https://510kreport.com/device/K232551
Methodology: https://510kreport.com/methodology