# K233865: X-Smart Pro; X-Smart Pro+

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Jul 24, 2024 after 231 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: 7 generations back to K971350 (1997). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202906: EndoPilot2, Schlumbohm GmbH & Co. KG (2021) Summary page 5.
- K151045: TENEO Dental Treatment Unit and Accessories, Sirona Dental Systems GmbH (2015) Summary page 5.

## Most influential descendants
- K251811: Motor and Apex Module (MaAM) (2025), 0 descendants of its own

## Indications for use
The Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.

Source page: https://510kreport.com/device/K233865
Methodology: https://510kreport.com/methodology