# K031204: Dentaport ZX

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Aug 21, 2003 after 127 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: 2 generations back to K970339 (1997). 2 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K071190: Root ZX II (2007), 6 descendants of its own
- K042822: TCM Endo V, Model 1534 (2004), 6 descendants of its own
- K150750: Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray (2015), 2 descendants of its own
- K090925: Multiple (Apex Locator), Model RCM-7 (2009), 2 descendants of its own
- K163402: NLZ Motor System (2017), 1 descendant of its own

## Indications for use
The DENTAPORT ZX 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/K031204
Methodology: https://510kreport.com/methodology