# K251811: Motor and Apex Module (MaAM)

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Aug 25, 2025 after 74 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 8 generations back to K971350 (1997). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163131: A-dec NLZ Electric Motor System, Nakanishi, Inc. (2017) Summary page 5.
- K150909: INTEGO Family and Accesories, Sirona Dental Systems GmbH (2015) Summary page 5.
- K151045: TENEO Dental Treatment Unit and Accessories, Sirona Dental Systems GmbH (2015) Summary page 5.
- K233865: X-Smart Pro; X-Smart Pro+, Dentsply Sirona, Inc. (2024) Summary page 5.

## Indications for use
The Midwest Motor Control Module includes a control unit, ports for three motors, an apex location port, and a peristaltic pump port. The motor ports are compatible with the Midwest Power Lux and Midwest Power Lux Implant. The Midwest Power Lux electric micromotor is intended for use as a drive for rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes. The Midwest Power Lux Implant motor is intended for use in implant placement and includes a closed system for delivery of sterile solution via peristaltic pump operation. The apex locator supports the dentist in the determination of the working length during the endodontic treatment. These motors are to be driven by the control unit. The control unit is an internal component of a dental delivery system. The use of this product is intended exclusively for duly qualified dental practitioners.

Source page: https://510kreport.com/device/K251811
Methodology: https://510kreport.com/methodology