# K990646: Portable Electric Motor-Handpiece Unit, Handy-Mate

- Pathway: 510(k) (Traditional)
- Applicant: Nsk Nakanishi, Inc.
- Decided: Mar 19, 1999 after 18 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need. - It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment. Special Note: The electric motor and its cord are not autoclavable: therefore, an adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary.

Source page: https://510kreport.com/device/K990646
Methodology: https://510kreport.com/methodology