# K011926: Elec-Mate E

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Sep 11, 2001 after 83 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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.

## Most influential descendants
- K083252: Nutorque Programmable Electric System (2009), 3 descendants of its own
- K090937: E-Statis 40 System (2009), 2 descendants of its own
- K163402: NLZ Motor System (2017), 1 descendant of its own
- K251701: Star E900 Electric System (2026), 0 descendants of its own

## Indications for use
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that drives a dc electric micromotor, and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of straight, right- and contra-angle ISO E-type attachment, with or without internal coolant, of equal, step-up, or step-down speed sheath. The maximum free speed of the electric micromotor is 40,000 rpm. Special Note: The electric micromotor and its cord are not autoclavable; therefore, an adequate covering by plastic sleeving as commonly used in dental for infection control method should be used during treatment.

Source page: https://510kreport.com/device/K011926
Methodology: https://510kreport.com/methodology