# K964860: Mark 20 and Mark 25 Hand Engine Controller

- Pathway: 510(k) (Traditional)
- Applicant: Bell Intl., Inc.
- Decided: Mar 3, 1997 after 89 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 25-D hand engine and C-310 Console (Controller): named in the summary without a submission number

## Most influential descendants
- K031584: Sirotorque L (2003), 13 descendants of its own
- K042759: Optima MX (2004), 11 descendants of its own
- K080677: Comfortronic 4894 and Comfortdrive 200XDA Handpiece (2008), 4 descendants of its own
- K103027: Electrotorque TLC (2011), 2 descendants of its own
- K090937: E-Statis 40 System (2009), 2 descendants of its own

## Indications for use
Engine, power supply and controller for dental handpiece

Source page: https://510kreport.com/device/K964860
Methodology: https://510kreport.com/methodology