# K990954: Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 Set

- Pathway: 510(k) (Traditional)
- Applicant: Nsk Nakanishi, Inc.
- Decided: Jun 9, 1999 after 79 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K112305: Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces (2012), 4 descendants of its own
- K141886: MDK Handpieces (2015), 3 descendants of its own
- K262144: DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (2026), 0 descendants of its own
- K251388: Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (2026), 0 descendants of its own
- K202786: Dental Low-speed Handpieces and Accessories (2021), 0 descendants of its own

## Indications for use
The device is a control unit that drives a dec electric micromotor and turns on or off the motor by its foot switch. It is intended for use 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 a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

Source page: https://510kreport.com/device/K990954
Methodology: https://510kreport.com/methodology