# K031584: Sirotorque L

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Aug 19, 2003 after 90 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
Longest line of descent: 1 generation back to K964860 (1997). 1 ancestor in all.
13 later devices descend from it; 4 cite 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)
- K964860: Mark 20 and Mark 25 Hand Engine Controller, Bell Intl., Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K201191: Elec-Led (2022), 1 descendant of its own

## Indications for use
The SiroTorque L is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces.

Source page: https://510kreport.com/device/K031584
Methodology: https://510kreport.com/methodology