# K242514: Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Rogin Medical Co., Ltd.
- Decided: Apr 24, 2025 after 244 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
Longest line of descent: 3 generations back to K970339 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203320: Endo Motor, Guilin Woodpecker Medical Instrument Co., Ltd. (2021) Summary page 5.

## Indications for use
Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canal while monitoring the position of the file tip inside the canal.

Source page: https://510kreport.com/device/K242514
Methodology: https://510kreport.com/methodology