# K202906: EndoPilot2

- Pathway: 510(k) (Traditional)
- Applicant: Schlumbohm GmbH & Co. KG
- Decided: Apr 13, 2021 after 196 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971350 (1997). 14 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153285: EMS-200, Meta Systems Co., Ltd. (2016) Summary page 5.
- K050895: Surpasson P5 Newtron, Satelec (2005) Summary page 5.

## Most influential descendants
- K233865: X-Smart Pro; X-Smart Pro+ (2024), 1 descendant of its own
- K251811: Motor and Apex Module (MaAM) (2025), 0 descendants of its own
- K242317: Integrated Endo System (Meet Endo-II) (2025), 0 descendants of its own
- K213947: Ultrasonic Endo Activation Device (Model:Actor I pro) (2022), 0 descendants of its own

## Indications for use
The EndoPilot 2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation. The EndoPilot 2 is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

Source page: https://510kreport.com/device/K202906
Methodology: https://510kreport.com/methodology