# K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor

- Pathway: 510(k) (Abbreviated)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Dec 15, 2009 after 257 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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 K970339 (1997). 1 ancestor in all.
11 later devices descend from it; 4 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)
- K970339: Tri Auto ZX, J. Morita USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K123582: Endo a Class (2013), 3 descendants of its own
- K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (2015), 2 descendants of its own
- K100600: Prosthodontic Screwdriver , Model IA-400 (2010), 2 descendants of its own
- K163402: NLZ Motor System (2017), 1 descendant of its own
- K143411: Traus Endo (2015), 1 descendant of its own

## Indications for use
Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument (»>ENDO file<<), which is intended by the manufacturer for use in the mechanical and rotary preparation of the root canal.

Source page: https://510kreport.com/device/K090931
Methodology: https://510kreport.com/methodology