# K990682: Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)

- Pathway: 510(k) (Traditional)
- Applicant: Nsk Nakanishi, Inc.
- Decided: Mar 24, 1999 after 21 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.
24 later devices descend from it; 2 cite it directly.
0 of 25 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
- K092614: X-Smart Easy (2009), 20 descendants of its own
- K111616: E-CUBE (2011), 10 descendants of its own
- K103653: E3 Torque Control Motor (2011), 8 descendants of its own
- K133298: Endo Smart (2014), 6 descendants of its own
- K153285: EMS-200 (2016), 5 descendants of its own

## Indications for use
This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.

Source page: https://510kreport.com/device/K990682
Methodology: https://510kreport.com/methodology