# K042759: Optima MX

- Pathway: 510(k) (Traditional)
- Applicant: Bien-Air SA Switzerland
- Decided: Oct 20, 2004 after 15 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964860 (1997). 2 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031584: Sirotorque L, Sirona Dental Systems GmbH (2003) Summary page 1.

## Most influential descendants
- 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
- K163402: NLZ Motor System (2017), 1 descendant of its own

## Indications for use
The Optima MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.

Source page: https://510kreport.com/device/K042759
Methodology: https://510kreport.com/methodology