# K031145: Estylus Electric Motor System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jul 15, 2003 after 96 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- 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 K983183 (1998). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P, Bien Air USA, Inc. (1998) Summary page 1.
- K013185: TCM Endo Iii, Nouvag AG (2001)

## Most influential descendants
- K072989: Axis System (2008), 8 descendants of its own
- K143704: Advanced Air System (2015), 7 descendants of its own
- K162926: Air-Powered Handpieces and Handpiece Attachments (2017), 6 descendants of its own
- K181858: Electric Handpiece Motor (2019), 4 descendants of its own
- K213022: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED (2022), 1 descendant of its own

## Indications for use
Used in general dentistry and endodontic dentistry for cutting, shaping,, filing, drilling, cleaning and polishing procedures

Source page: https://510kreport.com/device/K031145
Methodology: https://510kreport.com/methodology