# K042822: TCM Endo V, Model 1534

- Pathway: 510(k) (Traditional)
- Applicant: Nouvag AG
- Decided: Dec 22, 2004 after 71 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: 3 generations back to K970339 (1997). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031204: Dentaport ZX, J. Morita USA, Inc. (2003) Summary page 1.
- K022147: Denta Port, J. Morita USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (2015), 2 descendants of its own
- K163402: NLZ Motor System (2017), 1 descendant of its own
- K123608: Endo E Class (2013), 1 descendant of its own
- K251701: Star E900 Electric System (2026), 0 descendants of its own
- K141482: KI-20 (2015), 0 descendants of its own

## Indications for use
The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.

Source page: https://510kreport.com/device/K042822
Methodology: https://510kreport.com/methodology